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KEYU Norovirus Antigen Test Kit (Colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref NV-I
Identity
- Trade Name
- KEYU Norovirus Antigen Test Kit (Colloidal gold method) EUDAMED
- Device Name
- Norovirus Antigen Test Kit (Colloidal gold method) EUDAMED
- Model / Reference
- NV-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361856 EUDAMED
- Basic UDI-DI
- B-06974735361856 EUDAMED
- EMDN Code
- W0105040616 NOROVIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
KEYU Norovirus Antigen Test Kit (Colloidal gold method) by Zhuhai Keyu Biological Engineering Co., 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-06974735361856 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 1e73ea4f-37f9-4a6e-98be-981199fbeef8 61 fields · synced Jun 18, 2026