Cndh
by Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd. 40 variants
Ref 10/25/40/100 Tests/Kit
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-CNMF000020377SMULKITEB | Date3 Jul 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- One Step Multi-drug Screen Test Kit(Saliva) (Colloidal Gold )One Minute Marijuana (THC) Test Kit (Saliva) (Immunofluorescence)
- Model / Reference
- 10/25/40/100 Tests/Kit
- Primary DI / UDI-DI
- D-CNMF000020377SMULKITEB, D-CNMF000020377STHCIMF5
- Basic UDI-DI
- B-CNMF000020377SMULKITEB, B-CNMF000020377STHCIMF5
- EMDN Code
- W0102160599 Drugs of abuse/toxicology rt & poc - other
- Device Class
- Class IVD General
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000020377
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties
Other properties (4)
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Surgical Instrument: No