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GeneProof Ureaplasma PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref UUP/ISEX/025
Identity
- Trade Name
- GeneProof Ureaplasma PCR Kit EUDAMED
- Device Name
- GeneProof Ureaplasma PCR Kit EUDAMED
- Model / Reference
- UUP/ISEX/025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594161953319 EUDAMED
- Basic UDI-DI
- B-08594161953319 EUDAMED
- EMDN Code
- W0105011699 BACTERIOLOGY - NA REAGENTS - OTHER 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 Ureaplasma 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-08594161953319 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (2)
- EUDAMED 1732d191-3366-4c80-83a0-b863f9f614c1 61 fields · synced Jun 19, 2026
- EUDAMED ec48f8a6-4268-4c5a-968b-c9f1d0f1f945 61 fields · synced Jun 19, 2026