Urine Container
by Taizhou Kangwei Medical Instrument Co., Ltd. 20 variants
Ref 2LModel 5ml/10m/12ml/15ml/20ml/25ml/30ml/40ml/60ml/80ml/90ml/100ml/ 120ml/160ml/170ml/180ml/ 250ml/500ml/1L/2L
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 | Number697826803KWUCVM 06978268031996 | Date22 Jan 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- Withdrawn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
- Urine Container
- Model / Reference
- 5ml/10m/12ml/15ml/20ml/25ml/30ml/40ml/60ml/80ml/90ml/100ml/ 120ml/160ml/170ml/180ml/ 250ml/500ml/1L/2L, 2L
- Primary DI / UDI-DI
- 06978268031996
- Basic UDI-DI
- 697826803KWUCVM
- EMDN Code
- W05010203 Urine collection, containers
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045900
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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