Singclean
by Hangzhou Singclean Medical Products Co., Ltd. 18 variants
Ref MAU-02-20tModel Strip Cassette Midstream
Singclean (MAU-02-20t) is a Class C device made by Hangzhou Singclean Medical Products Co., Ltd., registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI 69360201228N), active as of 7 Nov 2026.
Active
CE IVDR
Valid until
30 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69360201228N 06936020116954 | Date16 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 69360201228N
Certificates
- IVDR 823880 Active
Technical documentation EU IVDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 1 Dec 2025
- Expires
- 30 Nov 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold)
- Model / reference
- Strip Cassette Midstream, MAU-02-20t
- Primary DI / UDI-DI
- 06936020116954
- Basic UDI-DI
- 69360201228N
- EMDN code
- W0102160101 Albumin incl. ualbumin rt & poc
- Device class
- Class C
- EU registration type
- Standard device
- EU market of registration
- France
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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