Accu-Answer
by Guilin Zhonghui Technology Co., Ltd. 2 variants
Ref Uric 10 CF, Uric 4VSG, Uric 2VGK, Uric 2VGP, Uric 3V, Uric 4V
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-693748520UX D-693748520UX | Date5 Mar 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Urinary Analysis Test Strips
- Model / Reference
- Uric 10 CF, Uric 4VSG, Uric 2VGK, Uric 2VGP, Uric 3V, Uric 4V
- Primary DI / UDI-DI
- D-693748520UX
- Basic UDI-DI
- B-693748520UX
- EMDN Code
- W0101060201 Urine single test strips (incl. tablets)
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000038423
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Guilin Zhonghui Technology Co., Ltd.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No