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QUCARE® Lipid test strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 6302
Identity
- Trade Name
- QUCARE® Lipid test strip EUDAMED
- Device Name
- Blood Monitoring System EUDAMED
- Model / Reference
- 6302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KR-MF-000015786LIPIDQ9 EUDAMED
- Basic UDI-DI
- B-KR-MF-000015786LIPIDQ9 EUDAMED
- EMDN Code
- W0101060109 MULTIPLE PARAMETER BLOOD TEST 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
QUCARE® Lipid test strip by DFI Co., Ltd. — 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-KR-MF-000015786LIPIDQ9 | Class IVD devices for self-testing | 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 7c293948-d31e-4213-8e0c-ca08ea723aef 61 fields · synced Jun 19, 2026