← Back to catalogue
QUCARE® Pro beta-hydroxybutyrate test strip
EUDAMEDClass IVD General (EU MDR)
Ref 6022
Identity
- Trade Name
- QUCARE® Pro beta-hydroxybutyrate test strip EUDAMED
- Device Name
- QUCARE® Pro EUDAMED
- Model / Reference
- 6022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KR-MF-000015786BHB9N EUDAMED
- Basic UDI-DI
- B-KR-MF-000015786BHB9N EUDAMED
- EMDN Code
- W0101060110 KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
QUCARE® Pro beta-hydroxybutyrate 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-000015786BHB9N | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DFI Co., Ltd.
- EUDAMED SRN
- KR-MF-000015786
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 86f94ae0-99b4-441f-b1c6-87da6d9877d8 61 fields · synced Jun 18, 2026