Radiofrequency Ablation Companies: Product/API, Lumex, LabEx and Medical Devices Map with Portfolio Evidence

Full 2026 v2 version: 71 companies; three layers are shown for every company: Product/API, Instrumental and Medical Devices; the Instrumental layer is split into separate Lumex and LabEx columns. Separate “Possibly relevant based on the public portfolio” suggestions were added for 0 companies using existing utilities only.

Companies

Layers per company

Catalog

Version

Companies with portfolio evidence

Product-specific suggestions

Radiofrequency Ablation Companies: Full Product/API, Lumex, LabEx and Medical Devices Map

The map shows the estimated fit of existing FUZKK utilities for 71 companies in: RF generators, catheters, probes, sterile kits, software and electrical safety. Three layers are shown for every company: Product/API, Instrumental and Medical Devices; the Instrumental layer is split into separate Lumex and LabEx columns.

The mapping is preliminary: it does not claim that a company has a specific product, instrument or software system. The actual portfolio, site, method and data format must be confirmed before a pilot.

Open the compact version Show packages tagged Medical Devices

71Companies

3Groups

3Layers per company

2026 v2Version

Three FUZKK layers

Product / APIProduct, API and domain-specific checks.

Global API & Biosimilars QC Suite

Lumex (Instrumental layer)Instrumental QC, calculations and instrument-data processing.

Lumex QC Suite

LabEx (Instrumental layer)Laboratory methods, microbiology and general QC workflows.

LabEx QC Suite

Medical DevicesDesign controls, risk, software, cybersecurity, sterilisation and QMS.

Medical Devices Standards & Lifecycle QC Suite

How to read product-specific suggestions

The yellow block is added only when a sufficiently precise public link to a medicine, isotope, test, platform or product line exists and a matching FUZKK utility is already available. “Possibly” means a preliminary portfolio-based fit, not confirmation of manufacture at a specific site or use of FUZKK. The absence of a yellow block means that public evidence is not yet precise enough or no matching product-specific utility exists.

Interventional, cardiac and surgical RF systems · 31 companies

Company	Product / API: base + possibly product-specific	Lumex (Instrumental layer)	LabEx (Instrumental layer)	Medical Devices
1. Medtronic Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
2. Boston Scientific Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
3. Abbott Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
4. Johnson & Johnson MedTech / Biosense Webster Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
5. AtriCure Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
6. AngioDynamics Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
7. Stryker Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
8. Olympus Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
9. Smith+Nephew Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
10. Avanos Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
11. Merit Medical Systems Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
12. Hologic Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
13. Baylis Medical Technologies / Boston Scientific Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
14. CONMED Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
15. Ethicon Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
16. Erbe Elektromedizin Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
17. BOWA Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
18. KLS Martin Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
19. Sutter Medizintechnik Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
20. inomed Medizintechnik Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
21. Diros Technology Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
22. Epimed Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
23. NeuroOne Medical Technologies Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
24. AtriAN Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
25. Kardium Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
26. MicroPort EP MedTech Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
27. BIOTRONIK Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
28. Japan Lifeline Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
29. Osypka Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
30. Lepu Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
31. Lifetech Scientific Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker

Tumour, pain and percutaneous ablation specialists · 20 companies

Company	Product / API: base + possibly product-specific	Lumex (Instrumental layer)	LabEx (Instrumental layer)	Medical Devices
32. STARmed Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
33. RF Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
34. Taewoong Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
35. ECO Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
36. Hangzhou Broncus Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
37. Mermaid Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
38. BVM Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
39. APRO Korea Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
40. MedSphere International Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
41. Boston Scientific Cosman Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
42. Avanos COOLIEF Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
43. Integra NeuroSciences Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
44. Theraclion Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
45. Creo Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
46. EMcision Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
47. AngioCare Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
48. MedWaves Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
49. NeuWave Medical / Johnson & Johnson Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
50. Vison Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker
51. Medtronic OsteoCool Estimated fit based on the group profile	Base checksParticulate Contamination Checker Sterility Result Evaluator Bioburden Checker Extractables Leachables Risk Assessor	Polymer ID EVA Polymer ID Polyethylene Polymer ID Polypropylene AAS Glass Leachables Test	Package Integrity & Leak Test Quality Checker Particle Count Injection USP <788> Quality Checker Environmental Monitoring Cleanroom Quality Checker FTIR Identity Quality Checker	Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Process Validation Checker

Dermatology, aesthetic and energy-based RF platforms · 20 companies

Company	Product / API: base + possibly product-specific	Lumex (Instrumental layer)	LabEx (Instrumental layer)	Medical Devices
52. InMode Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
53. Alma Lasers Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
54. Candela Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
55. Cynosure Lutronic Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
56. Venus Concept Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
57. Lumenis / Boston Scientific Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
58. Cutera Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
59. Solta Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
60. EndyMed Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
61. Jeisys Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
62. Lutronic Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
63. Apyx Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
64. Ellman International Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
65. Zimmer MedizinSysteme Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
66. INDIBA Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
67. Capenergy Medical Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
68. Soring Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
69. BTL Industries Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
70. DEKA Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker
71. Fotona Estimated fit based on the group profile	Base checksParticulate Contamination Checker Bioburden Checker Extractables Leachables Risk Assessor Sterility Result Evaluator	Polymer ID Polyethylene Polymer ID Polypropylene System Suitability Parameters Checker Polymer ID EVA	Package Integrity & Leak Test Quality Checker FTIR Identity Quality Checker Elemental Impurities ICP Quality Checker Particle Count Injection USP <788> Quality Checker	Electrical Safety Test Summary Checker EMCTest Coverage Checker Biocompatibility Gap Assessment Checker Software Safety Class Checker Design Control Compliance Checker

Company-list sources

Why choose FUZKK Utilities?

✅ Replace Excel

No hidden formulas or accidental edits. Deterministic logic, version control and reproducible results.

🔍 Audit-ready (IQ/OQ)

Each utility is supplied with URS & FS templates. This accelerates validation preparation and inspections.

⏱ Save QC time

Automate checks, calculations and reporting. The team focuses on deviations and scientific assessment rather than formatting.

🚀 Fast deployment

CSV input and JSON output allow integration without building heavy custom LIMS modules from scratch.

Integration workflow

LIMS / ELN / CSV export → FUZKK utility → output.json → QMS / eDMS / batch release

The utilities read CSV input and generate structured JSON output suitable for automated batch release, QA/QC review and LIMS/ELN/MES integration.

Utilities and checked parameters

#	API / product	Utility	Key checks
1	particulate-contamination-checker	`particulate contamination checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
2	sterility-result-evaluator	`sterility result evaluator`	Deterministic QC check from CSV input with JSON output for QA/QC review.
3	bioburden-checker	`bioburden checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
4	extractables-leachables-risk-assessor	`extractables leachables risk assessor`	Deterministic QC check from CSV input with JSON output for QA/QC review.
5	polymer-id-eva	`polymer id eva`	Deterministic QC check from CSV input with JSON output for QA/QC review.
6	polymer-id-polyethylene	`polymer id polyethylene`	Deterministic QC check from CSV input with JSON output for QA/QC review.
7	polymer-id-polypropylene	`polymer id polypropylene`	Deterministic QC check from CSV input with JSON output for QA/QC review.
8	aas-glass-leachables-test	`aas glass leachables test`	Deterministic QC check from CSV input with JSON output for QA/QC review.
9	system-suitability-parameters-checker	`system suitability parameters checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
10	package-integrity-leak-test-quality-checker	`package integrity leak test`	Deterministic QC check from CSV input with JSON output for QA/QC review.
11	particle-count-injection-usp788-quality-checker	`particle count injection usp788`	Deterministic QC check from CSV input with JSON output for QA/QC review.
12	environmental-monitoring-cleanroom-quality-checker	`environmental monitoring cleanroom`	Deterministic QC check from CSV input with JSON output for QA/QC review.
13	ftiridentity-quality-checker	`ftiridentity`	Deterministic QC check from CSV input with JSON output for QA/QC review.
14	elemental-impurities-icpquality-checker	`elemental impurities icpquality checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
15	design-control-compliance-checker	`design control compliance checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
16	risk-management-report-completeness-checker	`risk management report completeness checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
17	risk-control-traceability-checker	`risk control traceability checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
18	requirement-traceability-checker	`requirement traceability checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
19	process-validation-checker	`process validation checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
20	electrical-safety-test-summary-checker	`electrical safety test summary checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
21	emctest-coverage-checker	`emctest coverage checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
22	biocompatibility-gap-assessment-checker	`biocompatibility gap assessment checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.
23	software-safety-class-checker	`software safety class checker`	Deterministic QC check from CSV input with JSON output for QA/QC review.

Package positioning

The package is a marketing and technical selection. It is suitable for the first discussion with QC, portfolio coverage assessment, pilot scoping and integration planning.

three-layer four-column company map Product API Lumex LabEx Medical Devices company utility mapping rf medical-devices lifecycle risk management software lifecycle QMS company map radiofrequency-ablation-companies portfolio evidence product-specific utility fit possibly relevant public product portfolio 2026 v3 three FUZKK layers four utility columns Lumex Instrumental layer LabEx Instrumental layer 2026 v3.1

Licensing & support

License is granted to one pharmaceutical company or manufacturing site, with no redistribution rights.
Utilities are provided as is; validation is performed by the client using URS & FS / IQ/OQ templates.
Integration support is available for LIMS/ELN/MES, pilot preparation and CSV/JSON workflow clarification.
No public price is shown: the commercial proposal depends on package scope, number of sites, delivery model and support level.

Questions? Need a QC demo or pilot?

Representative — FUZKK Pharma Utilities

Open package in the portal