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SARS-CoV-2 Antigen Rapid Test Cassette
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref CG9011(S)-ANRef G1P-XRef G1S-XRef 06974323011880Ref G1P
Identity
- Device Name
- SARS-CoV-2 Antigen Rapid Test Cassette EUDAMED
- Model / Reference
- CG9011(S)-AN EUDAMEDG1P-X EUDAMEDG1S-X EUDAMED06974323011880 EUDAMEDG1P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323018988 EUDAMED06974323018995 EUDAMED06974323019497 EUDAMED06974323018858 EUDAMED06974323011897 EUDAMED06974323011880 EUDAMED06974323019480 EUDAMED06974323018803 EUDAMED06974323019701 EUDAMED06974323018834 EUDAMED06974323018841 EUDAMED06974323018827 EUDAMED06974323018919 EUDAMED06974323018926 EUDAMED06974323018902 EUDAMED06974323018957 EUDAMED
- Basic UDI-DI
- B-06974323018988 EUDAMEDB-06974323018995 EUDAMEDB-06974323019497 EUDAMEDB-06974323018858 EUDAMEDB-06974323011897 EUDAMEDB-06974323011880 EUDAMEDB-06974323019480 EUDAMEDB-06974323018803 EUDAMEDB-06974323019701 EUDAMEDB-06974323018834 EUDAMEDB-06974323018841 EUDAMEDB-06974323018827 EUDAMEDB-06974323018919 EUDAMEDB-06974323018926 EUDAMEDB-06974323018902 EUDAMEDB-06974323018957 EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMEDW0105041101 CORONAVIRUS AG EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass 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
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Antigen Rapid Test Cassette by Beijing Applied Biological Technologies Co., Ltd. — Class IVD devices for self-testing — 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-06974323018988 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (16)
- EUDAMED 3532b53c-2fb8-419a-ba3c-aa5f09c1f4da 61 fields · synced Sep 17, 2026
- EUDAMED d6cb00a1-6672-4f02-a5c6-eddf93e224ef 61 fields · synced May 16, 2026
- EUDAMED 6897a1e6-1a99-4984-9f08-728e99135ce4 61 fields · synced May 16, 2026
- EUDAMED 7806784c-e0be-4e6d-a079-47003ba322fe 61 fields · synced May 17, 2026
- EUDAMED d8af9d6a-8651-42a8-8794-ed642ee32e03 61 fields · synced May 17, 2026
- EUDAMED eb7a3d70-9b7e-4c76-97e3-80da24993347 61 fields · synced May 17, 2026
- EUDAMED 4f5caca5-6352-486a-8fb2-864cefec4f59 61 fields · synced May 17, 2026
- EUDAMED 53a5ed10-7c80-4916-b23c-60c4637ff38c 61 fields · synced May 18, 2026
- EUDAMED 161884b0-44a7-4de9-9f57-db31f9954734 61 fields · synced May 19, 2026
- EUDAMED 5667d592-bfe8-4a3d-9e9e-34e158e3e6dc 61 fields · synced May 19, 2026
- EUDAMED 217a0553-ad68-4046-9337-9cadd582ebdf 61 fields · synced May 19, 2026
- EUDAMED 3d7be4e5-198f-4719-af3e-5d0e3783bf49 61 fields · synced May 19, 2026
- EUDAMED d72e8c56-6662-4228-9b1e-53698febb33b 61 fields · synced Jul 9, 2026
- EUDAMED 31c60772-6c9c-48af-b6ea-8974af38d3fd 61 fields · synced Jul 14, 2026
- EUDAMED 50328734-bdc2-4099-8127-fdc6ebefab33 61 fields · synced Jul 25, 2026
- EUDAMED f3073041-a488-4b23-8b27-79c06e98279b 61 fields · synced Sep 17, 2026