Reagent Strips For Urinalysis
by Jiangsu Jinzhun Biotech Co., Ltd. EUDAMED
Active
Ref W0101060204Model JZ-11A, IS-11L，IS-10L，JZ-14A,JZ-10A, JZ-10M,URS-10T,JZ-3P,JZ-2G，URIC-10CF,URIC-3V,URIC-2GP
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-CN-MF-000027592TG | Date11 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Reagent Strips For Urinalysis
- Model / Reference
- JZ-11A, IS-11L，IS-10L，JZ-14A, JZ-10A, JZ-10M, URS-10T, JZ-3P, JZ-2G，URIC-10CF, URIC-3V, URIC-2GP, W0101060204
- Primary DI / UDI-DI
- D-CN-MF-000027592TG
- Basic UDI-DI
- B-CN-MF-000027592TG
- EMDN Code
- W0101060204 Urine multi-constituent test strips (manual)
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000027592
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Jiangsu Jinzhun Biotech Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No