Identity
- Trade Name
- ORAgene ONE EUDAMED
- Device Name
- ORAgene EUDAMED
- Model / Reference
- ON-600 EUDAMEDON-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00627595000637 EUDAMED00627595000620 EUDAMED
- Basic UDI-DI
- 0627595E0500GF EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES 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 ONE 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 (2)
- EUDAMED 094365b4-a576-4b3a-b280-5951bd5841ec 61 fields · synced Aug 3, 2026
- EUDAMED 85e2b5c0-5be4-4e06-8a79-f348a5977c9b 61 fields · synced May 17, 2026