Innovate Orthopaedics
GB-MF-000012886 · United Kingdom · Huddersfield
Innovate Orthopaedics is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 29 |
|---|---|
| Class IIa | 4 |
Most frequent device types declared: 10001, 10002R, 10003R, 10005, 10007.
Among these devices, 31 are declared sterile, 29 implantable, 2 reusable.
Authorised representative in the Union: Acorn Regulatory Consultancy Services Ltd.
Devices declared under this manufacturer
- Quick-Start
Showing 12 of 33 declared devices.
Catalogue references include 10001, 10002R, 10003R, 10005, 10007, 10013.
European nomenclature codes declared: P09120605, P091399, L26.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INNOVATE ORTHOPAEDICS LTD. (GB) · FDA 3022520753 |
| Devices in EUDAMED | 33 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 33 |
|---|---|
| Found in the U.S. device database | 33 |
| Share | 100.0 % |
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. Innovate Orthopaedics is registered in the United States but was not found in the Canadian register.