OTC Healthcare Limited
UK-MF-000052225 · United Kingdom · North Yorkshire
OTC Healthcare Limited is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: 853284, 853285.
Authorised representative in the Union: European Healthcare & Device Solutions Ltd..
Catalogue references include 853284, 853285, 853286, 853287, 853647, 853649.
European nomenclature codes declared: Y061209, Y060609, Y06120601, Y060615.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. OTC Healthcare Limited was not found in either the U.S. or the Canadian register.