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Uric Acid Test Strips
EUDAMEDClass IVD General (EU MDR)
Ref GUK-S025Model GUK S02
Identity
- Device Name
- Uric Acid Test Strips EUDAMED
- Model / Reference
- GUK S02 EUDAMEDGUK-S025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF000014455GUK-S025LH EUDAMED
- Basic UDI-DI
- B-CNMF000014455GUK-S025LH EUDAMED
- EMDN Code
- W01010699 CLIN. CHEM. RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Uric Acid Test Strips by Wuxi Biohermes Bio & Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-CNMF000014455GUK-S025LH | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuxi Biohermes Bio & Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014455
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 664ea06a-acb2-4904-9c7c-aadec5b66d5c 61 fields · synced Oct 6, 2026