V-URINE Test Cup
Ref LS3737Model V-URINE
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 | Number880935796VURINE87 08809357964865 | Date10 Jun 2026 | 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- Withdrawn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
- Model / Reference
- V-URINE, LS3737
- Primary DI / UDI-DI
- 08809357964865
- Basic UDI-DI
- 880935796VURINE87
- EMDN Code
- W05010203 Urine collection, containers
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000026779
- Authorised representative
- KTR Europe GmbH DE-AR-000005685
Other devices from AB Medical, Inc.
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