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2019-nCoV/Influenza A+B/RSV Antigen Combo Rapid Test Kit
EUDAMEDClass B (EU MDR)
Ref E11804Model 25 tests/box
Identity
- Trade Name
- 2019-nCoV/Influenza A+B/RSV Antigen Combo Rapid Test Kit EUDAMED
- Device Name
- 2019-nCoV/Influenza A+B/RSV Antigen Combo Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDE11804 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580781 EUDAMED
- Basic UDI-DI
- 697518250E118042B EUDAMED
- Direct Marketing DI
- 06942293580781 EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
2019-nCoV/Influenza A+B/RSV Antigen Combo Rapid Test Kit by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250E118042B | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED e6165884-73a0-45f3-871e-abefd78ff625 61 fields · synced Jul 11, 2026