Hart Biologicals Ltd.
GB-MF-000029121 · United Kingdom · Hartlepool
Hart Biologicals 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
Most frequent device types declared: HB-5504-FG, HB-5506-FG, HB-5508-FG, HB-5511-FG, HB-5515-FG.
Authorised representative in the Union: Amstermed UK Ltd.
Devices declared under this manufacturer
- Hart Biologicals
Showing 12 of 16 declared devices.
Catalogue references include HB-5504-FG, HB-5508-FG, HB-5511-FG, HB-5515-FG, HB-5533-FG, HB-5613-FG.
European nomenclature codes declared: W0103020401, W0103020217, W0103020403, W0103020404.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HART BIOLOGICALS LTD (GB) · FDA 3005261789 |
| Devices in EUDAMED | 16 |
| Country of registration | United Kingdom |
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. Hart Biologicals Ltd. is registered in the United States but was not found in the Canadian register.