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Uric Acid Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 4B003Model SPUGRef 1V003Model Safe AQ UG
Identity
- Device Name
- Uric Acid Test Strip EUDAMED
- Model / Reference
- SPUG EUDAMED4B003 EUDAMEDSafe AQ UG EUDAMED1V003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-01B0212YD EUDAMEDD-01B0206YJ EUDAMED
- Basic UDI-DI
- B-01B0212YD EUDAMEDB-01B0206YJ EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Uric Acid Test Strip by Changsha Sinocare Inc. — Class IVD devices for self-testing — 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-01B0212YD | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED aa9b9d13-86ef-475b-8264-8d754e9aa8c8 61 fields · synced Aug 3, 2026
- EUDAMED ee27cbe7-8a53-4f77-af03-7cda1bdcf18d 61 fields · synced May 18, 2026