Identity
- Trade Name
- ORAgene DNA EUDAMED
- Device Name
- ORAgene (Swab-based DNA & Dx Collection Device) EUDAMED
- Model / Reference
- OG-675 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00627595000668 EUDAMED
- Basic UDI-DI
- 0627595A0100EF EUDAMED
- EMDN Code
- A1101,W05019002 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ORAgene DNA by DNA Genotek Inc — Class A — 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 | 0627595A0100EF | Class A | Active |
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Manufacturer
- Manufacturer
- DNA Genotek Inc.
- EUDAMED SRN
- CA-MF-000003486
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 9ebdbfc1-b834-45fb-b040-5100de6712dd 61 fields · synced May 22, 2026