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QUCARE® Pro Blood Uric Acid test strip
EUDAMEDClass IVD General (EU MDR)
Ref 6032
Identity
- Trade Name
- QUCARE® Pro Blood Uric Acid test strip EUDAMED
- Device Name
- QUCARE® Pro EUDAMED
- Model / Reference
- 6032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KR-MF-000015786BUAAT EUDAMED
- Basic UDI-DI
- B-KR-MF-000015786BUAAT EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
QUCARE® Pro Blood Uric Acid test strip by DFI 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-KR-MF-000015786BUAAT | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DFI Co., Ltd.
- EUDAMED SRN
- KR-MF-000015786
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED d7c79434-f39b-46ef-80f3-b409e7f0eab7 61 fields · synced Jun 19, 2026