Identity
- Model / Reference
- oncofree EUDAMEDDCOF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 88000214000009 EUDAMED
- Basic UDI-DI
- B-88000214000009 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Dcof by DCGen 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-88000214000009 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DCGen Co., Ltd.
- EUDAMED SRN
- KR-MF-000026351
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (2)
- EUDAMED 40b41d7f-47ce-48a8-b020-e4de546d079c 61 fields · synced Jul 10, 2026
- EUDAMED 73a91748-690d-45d4-977d-ce8e0a9de08a 61 fields · synced Jul 10, 2026