Urine cup
by Nantong Shunwei Experimental Equipment Co., Ltd
Ref 5mlModel 10ml/20ml/30ml/40ml/60ml/80ml /100ml/120ml/150ml/200ml/250ml /500ml/1000ml
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 | Number697675184UrinecupL2 06976751840018 | Date20 Oct 2023 | 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- Withdrawn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
- Urine cup
- Model / Reference
- 10ml/20ml/30ml/40ml/60ml/80ml /100ml/120ml/150ml/200ml/250ml /500ml/1000ml, 5ml
- Primary DI / UDI-DI
- 06976751840018
- Basic UDI-DI
- 697675184UrinecupL2
- EMDN Code
- W05010203 Urine collection, containers
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000035422
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Properties
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No