Identity
- Trade Name
- ORAgene DNA EUDAMED
- Device Name
- ORAgene EUDAMEDORAgene (Swab-based DNA & Dx Collection Device) EUDAMED
- Model / Reference
- OG-510 EUDAMEDOG-575 EUDAMEDOG-600 EUDAMEDOG-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00627595000590 EUDAMED00627595000606 EUDAMED00627595000613 EUDAMED00627595000583 EUDAMED
- Basic UDI-DI
- 0627595E0500GF EUDAMED0627595A0100EF EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMEDA1101,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 | 0627595E0500GF | 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 (4)
- EUDAMED c53fa801-685b-41bc-abd6-62ae80e09340 61 fields · synced Jul 15, 2026
- EUDAMED 42b5a89d-1587-454a-90ec-1aa3ecc3518f 61 fields · synced May 17, 2026
- EUDAMED 7238da65-8595-4e48-9730-e8293154fb88 61 fields · synced May 18, 2026
- EUDAMED e56a5c63-130e-4c09-9902-ac511d4f6257 61 fields · synced May 19, 2026