EUDAMED device
ORAgene ONE
EUDAMED device 00627595000620 · DNA Genotek Inc.
Key facts
| Primary DI | 00627595000620 |
|---|---|
| Trade name | ORAgene ONE |
| Device name | ORAgene |
| Reference or catalog number | ON-500 |
| Manufacturer | DNA Genotek Inc. |
| Manufacturer SRN | CA-MF-000003486 |
| Risk class | Class A |
| EMDN code | W05019002 |
| EMDN description | SALIVA COLLECTION DEVICES |
| Legislation | ivdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Jul 7, 2025 |
At a glance
- No Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: