Cndh
by Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd. China EUDAMED
Ref H-COC-a08;H-COC-a07 EMDN W0102160506
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-H-COCTE | Date6 Jun 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- One Step Cocaine (COC) Test Device(Hair) (Immunofluorescence )
- Model / Reference
- H-COC-a08;H-COC-a07
- Primary DI / UDI-DI
- D-H-COCTE
- Basic UDI-DI
- B-H-COCTE
- EMDN Code
- W0102160506 Cocaine + cocaine metabolites - rt & poc
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000020377
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties & raw data
Show properties, registry sources and raw records
Other properties (5)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 99e296af-e3d0-4fb1-b957-4c40977bfbbf