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GeneProof PAI1 Genotyping PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref PAI1/025
Identity
- Trade Name
- GeneProof PAI1 Genotyping PCR Kit EUDAMED
- Device Name
- GeneProof PAI1 Genotyping PCR Kit EUDAMED
- Model / Reference
- PAI1/025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594161957010 EUDAMED
- Basic UDI-DI
- B-08594161957010 EUDAMED
- EMDN Code
- W0106010116 OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
GeneProof PAI1 Genotyping PCR Kit by GeneProof a.s. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08594161957010 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (1)
- EUDAMED 278b4146-b6a1-4f76-a4fd-d130f92142b8 61 fields · synced Jul 20, 2026