Open Bionics Ltd.
GB-MF-000032650 · United Kingdom · Bristol
Open Bionics Ltd. is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 16 |
|---|
Most frequent device types declared: 3000071, 3000077, 3000080, 4001004, 5001015.
Among these devices, 1 are declared active.
Authorised representative in the Union: European Healthcare & Device Solutions Ltd..
Devices declared under this manufacturer
- Builder
- Cobra
- Drummer
- Hero Arm
- Hero Flex
- Hero Gauntlet
- Hero Lite
- Hero PRO
- Hero RGD
- Monkey
- MyoPods
- Prana
Showing 12 of 16 declared devices.
Catalogue references include 3000076, 3000078, 3000080, 300073, 5001015, 5001023.
European nomenclature codes declared: Y060680, P090299,P090399,P090499,Y060680,Z12062705, P090299,P090399,P090499,Z12062705, P090499, P090299,P090399,P090499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OPEN BIONICS (GB) · FDA 3012881757 |
| Devices in EUDAMED | 16 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| 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. Open Bionics Ltd. is registered in the United States but was not found in the Canadian register.