Identity
- Trade Name
- GenBody KET EUDAMED
- Model / Reference
- DKET010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076700918 EUDAMED
- Basic UDI-DI
- B-08800076700918 EUDAMED
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
GenBody KET by Genbody Inc. — 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-08800076700918 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GenBody Inc.
- EUDAMED SRN
- KR-MF-000043626
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 12f81db8-5703-41cb-aaef-eb4b25bdcf49 61 fields · synced Jul 17, 2026