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Triplex Real-time PCR Diagnostic Kit for Rapid Detection of C. jejuni, C. coli …
EUDAMEDClass IVD General (EU MDR)
Ref A2503
Identity
- Device Name
- Triplex Real-time PCR Diagnostic Kit for Rapid Detection of C. jejuni, C. coli and C. lari EUDAMED
- Model / Reference
- A2503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323011491 EUDAMED06974323011507 EUDAMED
- Basic UDI-DI
- B-06974323011491 EUDAMEDB-06974323011507 EUDAMED
- EMDN Code
- W0105011402 CAMPYLOBACTER 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
Triplex Real-time PCR Diagnostic Kit for Rapid Detection of C. jejuni, C. 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-06974323011491 | 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 309b0e6f-01e2-4686-97f1-cc3b71ac6815 61 fields · synced Jul 20, 2026
- EUDAMED 9b784cd4-a277-4849-88b9-2d9a5d906983 61 fields · synced May 18, 2026