Multiple Drugs of Abuse Rapid Tests
by Nantong EgensBiotechnology Co., Ltd.
Ref Multiple Drugs of Abuse strip cassette
Withdrawn
CE IVDD, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-693757992601QM D-693757992601QM | Date14 Nov 2023 | StatusWithdrawn |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Withdrawn
Specification
- Model / Reference
- Multiple Drugs of Abuse strip cassette
- Primary DI / UDI-DI
- D-693757992601QM
- Basic UDI-DI
- B-693757992601QM
- EMDN Code
- W0102160511 Multiple drugs of abuse/toxicology rt & poc
- Device Class
- Class IVD General
Manufacturer details
- EUDAMED SRN
- CN-MF-000021561
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Nantong EgensBiotechnology Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No