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Real-Time PCR Diagnostic Kit for Rapid Detection of Respiratory Adenovirus
EUDAMEDClass IVD General (EU MDR)
Ref A7371
Identity
- Device Name
- Real-Time PCR Diagnostic Kit for Rapid Detection of Respiratory Adenovirus EUDAMED
- Model / Reference
- A7371 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323011316 EUDAMED
- Basic UDI-DI
- B-06974323011316 EUDAMED
- EMDN Code
- W0105040501 ADENOVIRUS - 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
Real-Time PCR Diagnostic Kit for Rapid Detection of Respiratory Adenovirus by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — 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-06974323011316 | 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 (1)
- EUDAMED 24d52469-dee4-469d-a359-aa1ed38df33b 61 fields · synced Jul 10, 2026