Helena Biosciences Europe
GB-MF-000028365 · United Kingdom · Gateshead
Helena Biosciences Europe is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 200601, 200602, 201201, 201202, 3218.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Cholesterol Control
- Immunotyping Control
- REP/SPIFE SP 180 Kit
- REP/SPIFE SP 300 Kit
- REP/SPIFE SP 600 Kit
- SAS-1 Cholesterol Profile Kit
- SAS-3 SP-60 Kit
- SAS-MX SP-10 Kit
- Serum Protein Abnormal Control
- Thromboplastin L
- UltraCE IFE Diluent
- UltraCE Maintenance Buffer
Showing 12 of 25 declared devices.
Catalogue references include 100100, 200601, 3145, 5267L, V150, V8010.
European nomenclature codes declared: W0102019099, W0201050101, W0103020101, W01010205, W0102152003, W01010115.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 25 |
| 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 | 25 |
|---|---|
| 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. Helena Biosciences Europe was not found in either the U.S. or the Canadian register.