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SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref CG9092(S)-AN
Identity
- Device Name
- SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette EUDAMED
- Model / Reference
- CG9092(S)-AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323018650 EUDAMED
- Basic UDI-DI
- B-06974323018650 EUDAMED
- EMDN Code
- W0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette by Beijing Applied Biological Technologies Co., Ltd. — Class IVD devices for self-testing — IVDD…
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-06974323018650 | Class IVD devices for self-testing | 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 (1)
- EUDAMED 838e037f-a359-4bd5-9bac-9cafd7ef4bff 61 fields · synced Oct 6, 2026