Singclean®
by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED
Ref MOP-02-25tModel Cassette: 25 test/box
EMDN W0102090112
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-MOP-02-25tT6 | Date18 Dec 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Morphine (MOP) One Step Test Kit (Colloidal Gold Method)
- Model / Reference
- Cassette: 25 test/box, MOP-02-25t
- Primary DI / UDI-DI
- D-MOP-02-25tT6
- Basic UDI-DI
- B-MOP-02-25tT6
- EMDN Code
- W0102090112 Morphines
- 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 & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED bbc7c059-d082-47a9-896f-362c2aa07b7d