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Multiplex PCR Detection Kit for 5 Diarrheagenic Escherichia coli
EUDAMEDClass IVD General (EU MDR)
Ref A211LFD-48TRef A211LFD-24T
Identity
- Device Name
- Multiplex PCR Detection Kit for 5 Diarrheagenic Escherichia coli EUDAMED
- Model / Reference
- A211LFD-48T EUDAMEDA211LFD-24T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323013075 EUDAMED06974323013068 EUDAMED
- Basic UDI-DI
- B-06974323013075 EUDAMEDB-06974323013068 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 Detection Kit for 5 Diarrheagenic Escherichia coli by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974323013075 | 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 7c84213a-69c2-49d5-8ba3-eb3333c3953a 61 fields · synced Jul 25, 2026
- EUDAMED 408b8848-f854-4b25-b650-db75d6a04a16 61 fields · synced May 17, 2026