OPED GmbH
DE-MF-000008286 · Germany · Valley/Oberlaindern
OPED GmbH is registered in the European database on medical devices as a manufacturer, with 95 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 92 |
|---|---|
| Class IIb | 3 |
Most frequent device types declared: EVENup, VXSY-10-1.
Among these devices, 7 are declared active.
Devices declared under this manufacturer
- Orthelligent PRO
- Orthelligent VISION
- VADOplex Fußpad
- VXSY-1-1-PL
- VXSY-1-1-SE
- VXSY-1-1-SI
- VXSY-10-1-DE
- VXSY-10-1-FI
- VXSY-10-1-IT
- VXSY-10-1-NL
Showing 12 of 95 declared devices.
Catalogue references include ADKN-01-1-S, AUSG-01-4-M, OPHA-01-1-S/M, POLL-03-1-S-LI, SUKN-01-3-60, SUKN-R-01-3-40.
European nomenclature codes declared: Y061209, Y060606, Y060621, Z120607, Y063303, M030405.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OPED GmbH (DE) · FDA 3009718162 |
| Devices in EUDAMED | 95 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 95 |
|---|---|
| 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: United States only. OPED GmbH is registered in the United States but was not found in the Canadian register.