Yourgene Health UK Ltd
GB-MF-000024810 · United Kingdom · Manchester
Yourgene Health UK Ltd 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
Most frequent device types declared: ONDYDB1.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Yourgene® Cystic Fibrosis Base
- Yourgene® DPYD
- Yourgene® QST*R Base
Catalogue references include 10141010, 10141020, 10141040, AN0PLB2, CF2EUB2, ONDYDB1.
European nomenclature codes declared: W0106010306, W0106030101, W0106010101.
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 | Licensed in Canada |
|---|---|
| Matched entry | YOURGENE HEALTH UK LTD |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 9 |
| First licensed | 2006-06-15 |
Licence types: Test Kit (8), Single Device (1).
Licensed under: YOURGENE QST*R BASE, YOURGENE QST*R PLUS XY, YOURGENE QST*R PLUS TRISOMY 13, YOURGENE QST*R PLUS TRISOMY 21, YOURGENE QST*R PLUS TRISOMY 18, YOURGENE MALE FACTOR INFERTILITY PLUS.
North American profile: Canada only. Yourgene Health UK Ltd holds a Canadian licence but was not found in the U.S. register.