Detergent
by URIT Medical Electronic Co., Ltd. 4 variants
Ref /Model URIT D16
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69357407IUSS0000052F 06935740723251 | Date5 Aug 2025 | StatusActive |
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- Withdrawn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/IVDR Active
Specification
- Device Name
- Detergent
- Model / Reference
- URIT D16, /
- Primary DI / UDI-DI
- 06935740723251
- Basic UDI-DI
- 69357407IUSS0000052F
- EMDN Code
- W0101060299 Urine testing - other
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011840
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from URIT Medical Electronic 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
- New Device: No