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Drugs of Abuse Rapid Test Kit
EUDAMEDClass B (EU MDR)
Ref G12700Model 25 tests/box
Identity
- Trade Name
- Drugs of Abuse Rapid Test Kit EUDAMED
- Device Name
- Drugs of Abuse Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDG12700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581412 EUDAMED
- Basic UDI-DI
- 697518250G127002X EUDAMED
- Direct Marketing DI
- 06942293581412 EUDAMED
- EMDN Code
- W0102090199 DRUGS OF ABUSE - 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
Drugs of Abuse Rapid Test Kit by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697518250G127002X | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED c7219467-04cb-4a6f-b855-5b27fadcd414 61 fields · synced Jul 17, 2026