Identity
- Trade Name
- ComboStik 11M EUDAMED
- Device Name
- ComboStik Series EUDAMED
- Model / Reference
- ComboStik Series EUDAMED2A04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806141304722 EUDAMED
- Basic UDI-DI
- 88061413US32D0JH EUDAMED
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
ComboStik 11M by DFI Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88061413US32D0JH | Class B | 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 5ca1eca3-da49-4741-936f-51f53d637d69 61 fields · synced Jul 9, 2026