Okuvision GmbH
DE-MF-000006119 · Germany · Reutlingen
Okuvision GmbH is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: OkuEl Counter Electrode, OkuEl Electrode Package, OkuEl M, OkuEl M Package, OkuSpex.
Among these devices, 1 are declared active.
Devices declared under this manufacturer
- OkuEl Counter Electrode
- OkuEl Electrode
- OkuEl Electrode Package
- OkuEl M
- OkuEl M Package
- OkuSpex
- OkuStim Pulse
- OkuStim Pulse Lite
Catalogue references include OK100052, OK100305, OK100310, OK200003, OK200004, OK200005.
European nomenclature codes declared: Z12101185, Z12101182, Z12101106, Z12100385, Q0299, Z12101180.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Okuvision GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1653884-1 | amended | 2028-11-27 |