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Multiple Real-Time PCR Kit for Detection of 2019-nCoV
EUDAMEDClass IVD General (EU MDR)
Ref A7793YF-50TRef A7793YF-100TRef CT8223-24TRef ID019
Identity
- Device Name
- Multiple Real-Time PCR Kit for Detection of 2019-nCoV EUDAMED
- Model / Reference
- A7793YF-50T EUDAMEDA7793YF-100T EUDAMEDCT8223-24T EUDAMEDID019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012337 EUDAMED06974323012344 EUDAMED06974323012351 EUDAMED06974323012887 EUDAMED06974323012894 EUDAMED
- Basic UDI-DI
- B-06974323012337 EUDAMEDB-06974323012344 EUDAMEDB-06974323012351 EUDAMEDB-06974323012887 EUDAMEDB-06974323012894 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS 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
Multiple Real-Time PCR Kit for Detection of 2019-nCoV 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-06974323012337 | 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 (5)
- EUDAMED fdd973ad-eb21-4999-bff6-95019914d01b 61 fields · synced Jul 27, 2026
- EUDAMED f6024917-9f8b-4d0f-96cc-6f731e73cbcf 61 fields · synced May 18, 2026
- EUDAMED 7ee3e1b1-8261-4305-aaa9-5dee92513ce1 61 fields · synced May 19, 2026
- EUDAMED 3701a96c-9b56-4de1-b48a-c33dcebd8b62 61 fields · synced Jul 11, 2026
- EUDAMED 8b5aed05-b770-4459-9a5c-902a2a193e73 61 fields · synced Jul 22, 2026