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ZENA MAX Candida Auris Real Time PCR Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref KD919161-100
Identity
- Device Name
- ZENA MAX Candida Auris Real Time PCR Detection Kit EUDAMED
- Model / Reference
- KD919161-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061059980458 EUDAMED
- Basic UDI-DI
- B-05061059980458 EUDAMED
- EMDN Code
- W0105060499 MYCOLOGY NA REAGENTS - OTHER 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 Candida Auris 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-05061059980458 | 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 b23646f9-f6ba-4478-b35b-32c68af18c12 61 fields · synced Aug 4, 2026