Singclean®
by Hangzhou Singclean Medical Products Co., Ltd. EUDAMED
Active
Ref MET-02-25t
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-MET-02-25tNC | Date18 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Methamphetamine (MET) One Step Test Kit (Colloidal Gold Method)
- Model / Reference
- MET-02-25t
- Primary DI / UDI-DI
- D-MET-02-25tNC
- Basic UDI-DI
- B-MET-02-25tNC
- EMDN Code
- W0102090110 Methadone
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014098
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Hangzhou Singclean Medical Products Co., Ltd.
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Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No