Prima Medical Ltd
UK-MF-000045180 · United Kingdom · Stonehouse
Prima Medical Ltd is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 7 |
|---|---|
| Class IIa | 4 |
Among these devices, 7 are declared sterile, 9 active.
Authorised representative in the Union: Obelis s.a..
Devices declared under this manufacturer
- ActiSeal
- ClearAir2
- Cotswold Needles
- GREEN Filter
- MacroSeal
- Retract
- SuperVac
Catalogue references include AS8XXX, GFU001 / CFU001, MS8XXX, PMS16XX, PMS25X, PMS29XX, PMS395X, LESXXX, PMS17XX, PMS3XXX.
European nomenclature codes declared: K0201010501, K0201010601, Z12019004, K020180, K0201010301, K0201010301,K0201010302.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| 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 | 4 |
|---|---|
| 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. Prima Medical Ltd was not found in either the U.S. or the Canadian register.