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Carbapenem Resistant Enterobacteriaceae Rapid Test Kit
EUDAMEDClass B (EU MDR)
Ref 697518250E118062FModel 25 tests/box
Identity
- Trade Name
- Carbapenem Resistant Enterobacteriaceae Rapid Test Kit EUDAMED
- Device Name
- Carbapenem Resistant Enterobacteriaceae Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMED697518250E118062F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293582044 EUDAMED
- Basic UDI-DI
- 697518250E118062F EUDAMED
- Direct Marketing DI
- 06942293582044 EUDAMED
- EMDN Code
- W0105011799 BACTERIOLOGY IMMUNOASSAY - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
Carbapenem Resistant Enterobacteriaceae Rapid Test Kit by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250E118062F | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 445a1cf5-0e6c-4887-a65c-678050850648 61 fields · synced Jul 13, 2026