Sumed International (UK) Ltd
GB-MF-000029110 · United Kingdom · Derbyshire
Sumed International (UK) Ltd is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 18 |
|---|
Most frequent device types declared: HEELSAFE, Hadfield Boot, Integrity, Integrity V AIR, Uniroll.
Authorised representative in the Union: Sumed Healthcare Ireland Ltd.
Devices declared under this manufacturer
- HEELSAFE
- Hadfield Boot
- Integrity
- Integrity Static Cushion
- Integrity Static Cushion High Risk
- Integrity Static Cushion Low Risk
- Integrity Static Cushion Medium Risk
- Integrity Static Cushion Very High Risk
- UNIROLL
- Uniroll
Showing 12 of 18 declared devices.
Catalogue references include HSPSM, HSVL, HSVM, HSVS, INTH17W1818WD, INTSTATAIR1818.
European nomenclature codes declared: Y090618, Y180980, Y122106, Y091212, V08060101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 18 |
|---|---|
| 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. Sumed International (UK) Ltd was not found in either the U.S. or the Canadian register.