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2019-nCoV Antigen Rapid Test Cassette
EUDAMEDClass IVD General (EU MDR)
Ref CG9011-25T-ORef CG9011-20T-ORef CG9011-1T-NRef CG9011-60T-ANRef CG9011-5T-ANRef CG9011-40T-ORef CG9011-60T-NRef CG9011-1T-ORef CG9011-1T-ANRef CG9011-20T-ANRef 2019-nCoV Antigen Rapid Test CassetteRef CG9011-30T-ORef CG9011-50T-NRef CG9011-10T-NRef CG9041
Identity
- Device Name
- 2019-nCoV Antigen Rapid Test Cassette EUDAMED
- Model / Reference
- CG9011-25T-O EUDAMEDCG9011-20T-O EUDAMEDCG9011-1T-N EUDAMEDCG9011-60T-AN EUDAMEDCG9011-5T-AN EUDAMEDCG9011-40T-O EUDAMEDCG9011-60T-N EUDAMEDCG9011-1T-O EUDAMEDCG9011-1T-AN EUDAMEDCG9011-20T-AN EUDAMED2019-nCoV Antigen Rapid Test Cassette EUDAMEDCG9011-30T-O EUDAMEDCG9011-50T-N EUDAMEDCG9011-10T-N EUDAMEDCG9041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323016960 EUDAMED06974323016892 EUDAMED06974323014997 EUDAMED06974323014881 EUDAMED06974323014812 EUDAMED06974323017080 EUDAMED06974323017134 EUDAMED06974323014980 EUDAMED06974323014805 EUDAMED06974323014836 EUDAMED06974323016878 EUDAMED06974323016984 EUDAMED06974323017110 EUDAMED06974323016885 EUDAMED06974323014966 EUDAMED06974323014973 EUDAMED06974323014928 EUDAMED06974323014942 EUDAMED06974323014904 EUDAMED06974323014935 EUDAMED
- Basic UDI-DI
- B-06974323016960 EUDAMEDB-06974323016892 EUDAMEDB-06974323014997 EUDAMEDB-06974323014881 EUDAMEDB-06974323014812 EUDAMEDB-06974323017080 EUDAMEDB-06974323017134 EUDAMEDB-06974323014980 EUDAMEDB-06974323014805 EUDAMEDB-06974323014836 EUDAMEDB-06974323016878 EUDAMEDB-06974323016984 EUDAMEDB-06974323017110 EUDAMEDB-06974323016885 EUDAMEDB-06974323014966 EUDAMEDB-06974323014973 EUDAMEDB-06974323014928 EUDAMEDB-06974323014942 EUDAMEDB-06974323014904 EUDAMEDB-06974323014935 EUDAMED
- EMDN Code
- W0105041101 CORONAVIRUS AG 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
2019-nCoV Antigen Rapid Test Cassette by Beijing Applied Biological Technologies 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-06974323016960 | 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 (20)
- EUDAMED 17f136f9-96a9-4e4e-8481-799dff6b4d12 61 fields · synced Oct 7, 2026
- EUDAMED 57793ed6-a829-430d-bea1-ef496024b3a8 61 fields · synced May 16, 2026
- EUDAMED 55a4b43a-2e13-4335-bcdf-237ebc35712f 61 fields · synced May 16, 2026
- EUDAMED 16bf03b1-636e-491d-92ec-5162a4517ab1 61 fields · synced May 17, 2026
- EUDAMED 8d78d3b7-6770-4643-8386-4abb48e886f0 61 fields · synced May 17, 2026
- EUDAMED 86bf6c97-ded6-45ea-a53e-5089670057f8 61 fields · synced May 17, 2026
- EUDAMED 133f4978-30ca-4e83-a841-7060ac009025 61 fields · synced May 17, 2026
- EUDAMED a3a5284b-9a90-449f-80f5-5579fc96b741 61 fields · synced May 18, 2026
- EUDAMED dbe4a9c8-c313-49f5-b1dc-8b8fd21d561a 61 fields · synced May 18, 2026
- EUDAMED 320f66de-60c7-4a76-ab8a-3183b690f2ef 61 fields · synced May 18, 2026
- EUDAMED ce0e3d4e-2a2d-4a26-8061-03d248ebeeca 61 fields · synced May 18, 2026
- EUDAMED 2955d602-1cdb-41ad-b350-31b36eaf3e7b 61 fields · synced May 19, 2026
- EUDAMED a8995685-4948-4a28-afbc-2f45938fd293 61 fields · synced May 19, 2026
- EUDAMED 505c0240-3774-4840-a936-e33434349dfc 61 fields · synced May 19, 2026
- EUDAMED 2686226d-8e32-4cf7-9998-f0616e336c17 61 fields · synced Jul 9, 2026
- EUDAMED 5f1270f0-ed84-4151-b802-ea04eadc9b3d 61 fields · synced Jul 12, 2026
- EUDAMED 758e4bc7-686b-4403-b8f8-9eb691bd7b63 61 fields · synced Jul 14, 2026
- EUDAMED 3c0ccef3-4b4b-4ad5-b82a-5f3d2b2e5fac 61 fields · synced Jul 17, 2026
- EUDAMED 116c0cb6-88b0-476b-9b16-ef7570539b60 61 fields · synced Jul 22, 2026
- EUDAMED b6c3c9fd-0294-40c5-9d18-75e48594543f 61 fields · synced Jul 26, 2026