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Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Vir…
EUDAMEDClass IVD General (EU MDR)
Ref A9106Ref CG9092(S)-AN
Identity
- Device Name
- Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Viruses EUDAMED
- Model / Reference
- A9106 EUDAMEDCG9092(S)-AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012498 EUDAMED06974323018575 EUDAMED
- Basic UDI-DI
- B-06974323012498 EUDAMEDB-06974323018575 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS EUDAMEDW0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass IVD devices for self-testing 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
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Multiplex Real-time PCR Diagnostic Kit for Rapid Detection of Six Diarrheal Vir… by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General…
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-06974323012498 | 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 (2)
- EUDAMED 1862c287-c087-4a72-bce6-b9bafd519625 61 fields · synced Jul 24, 2026
- EUDAMED 543bfe86-8120-4079-9e37-d7e7cd5d6ece 61 fields · synced May 18, 2026