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Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Meth…
EUDAMEDClass IVD General (EU MDR)
Ref CG9063
Identity
- Device Name
- Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method) EUDAMED
- Model / Reference
- CG9063 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323018766 EUDAMED06974323018742 EUDAMED
- Basic UDI-DI
- B-06974323018766 EUDAMEDB-06974323018742 EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Meth… by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General…
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-06974323018766 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED eeeded58-9503-43ae-b129-fdc8f5f041d9 61 fields · synced Jul 10, 2026
- EUDAMED d5c81ca2-7a27-4968-aa1e-f2466cebe889 61 fields · synced May 17, 2026