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ZENA MAX Papillomavirus (HPV) Type 16 and 18 Real Time PCR Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref KD197241-100
Identity
- Device Name
- ZENA MAX Papillomavirus (HPV) Type 16 and 18 Real Time PCR Detection Kit EUDAMED
- Model / Reference
- KD197241-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061059980564 EUDAMED
- Basic UDI-DI
- B-05061059980564 EUDAMED
- EMDN Code
- W0105041002 SCREENING HIGH-RISK HPV - NA REAGENTS 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ZENA MAX Papillomavirus (HPV) Type 16 and 18 Real Time PCR Detection 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-05061059980564 | 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 721fb01a-b34f-4462-97bc-5c915bb7eead 61 fields · synced Jun 18, 2026