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Real-time PCR Diagnostic Kit for Rapid Detection of Enterohemorrhagic E. coli (…
EUDAMEDClass IVD General (EU MDR)
Ref A5454
Identity
- Device Name
- Real-time PCR Diagnostic Kit for Rapid Detection of Enterohemorrhagic E. coli (EHEC) EUDAMED
- Model / Reference
- A5454 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323011309 EUDAMED06974323011293 EUDAMED
- Basic UDI-DI
- B-06974323011309 EUDAMEDB-06974323011293 EUDAMED
- EMDN Code
- W0105011503 E. COLI DETECTION BY 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 Enterohemorrhagic E. coli (… 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-06974323011309 | 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 67212448-8a9c-42dd-80ad-73b9bd6ab38a 61 fields · synced Oct 6, 2026
- EUDAMED ff485b64-612a-4aa5-9e9d-021db501e7fb 61 fields · synced May 19, 2026