BioFynder Limited
UK-MF-000047512 · United Kingdom · Southampton
BioFynder Limited is registered in the European database on medical devices as a manufacturer, with 134 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: TA100, TC100, TC600, TG100, TH100.
Authorised representative in the Union: SUNGO Europe B.V..
Devices declared under this manufacturer
- TruAna
- TruCell
- TruDerma
- TruGlyc
- TruHemo
- TruLyta
- TruOx
- TruReno
- TruUri
- TruVue
Showing 12 of 134 declared devices.
Catalogue references include TC10003, TC60001, TH10001, TR10002, TV10020, TV10029.
European nomenclature codes declared: W01010404, W0105099007, W0102160302, W0102160511, W0102160699, W0102160304.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 134 |
| 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 | 134 |
|---|---|
| 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. BioFynder Limited was not found in either the U.S. or the Canadian register.