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Multiplex PCR Diagnostic Kit for Rapid Detection of Five Genera of Diarrheogeni…
EUDAMEDClass IVD General (EU MDR)
Ref A3943FD-48T
Identity
- Device Name
- Multiplex PCR Diagnostic Kit for Rapid Detection of Five Genera of Diarrheogenic E. coli (GB.V.)(Freeze-dried Type) EUDAMED
- Model / Reference
- A3943FD-48T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323013099 EUDAMED
- Basic UDI-DI
- B-06974323013099 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX 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
Multiplex PCR Diagnostic Kit for Rapid Detection of Five Genera of Diarrheogeni… 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-06974323013099 | 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 10c1d0e4-66f0-416b-ab50-af374c73140d 61 fields · synced Jul 29, 2026