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ZENA MAX Human Factor II Prothrombin “20210 Mutation” Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref KD184567-100
Identity
- Device Name
- ZENA MAX Human Factor II Prothrombin “20210 Mutation” Real Time PCR Kit EUDAMED
- Model / Reference
- KD184567-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061059980199 EUDAMED
- Basic UDI-DI
- B-05061059980199 EUDAMED
- EMDN Code
- W0106010114 PROTHROMBIN MUTATION EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Malta 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ZENA MAX Human Factor II Prothrombin “20210 Mutation” Real Time PCR Kit by Advanced Molecular Diagnostics Ltd — Class IVD General — IVDD — listed in EUDAMED
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-05061059980199 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Advanced Molecular Diagnostics Ltd
- EUDAMED SRN
- UK-MF-000043044
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 94ad340c-7823-4669-a381-997b7d5de285 61 fields · synced Jun 19, 2026