Identity
- Trade Name
- ComboStik 13 EUDAMED
- Device Name
- ComboStik Series EUDAMED
- Model / Reference
- 2C04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KR-MF-000015786PROCSTT EUDAMED
- Basic UDI-DI
- B-KR-MF-000015786PROCSTT EUDAMED
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - 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
ComboStik 13 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-000015786PROCSTT | 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 20ebbb32-a002-4a2d-8123-53e4a097f186 61 fields · synced Jun 18, 2026