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51333701, 51333705, 51333720, 51333725
EUDAMEDClass IVD General (EU MDR)
Ref 51333701,51333705,51333720,51333725
Identity
- Device Name
- 51333701,51333705,51333720,51333725 EUDAMED
- Model / Reference
- 51333701,51333705,51333720,51333725 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-513337NW EUDAMED
- Basic UDI-DI
- B-513337NW EUDAMED
- EMDN Code
- W0105040616 NOROVIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
51333701, 51333705, 51333720, 51333725 by Xiamen Wiz Biotech Co., Ltd. — 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-513337NW | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Wiz Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000029590
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 0808003b-6127-41d4-9b1a-065824bd5a96-1 61 fields · synced Sep 30, 2026
- EUDAMED 0808003b-6127-41d4-9b1a-065824bd5a96-2 61 fields · synced Sep 30, 2026