PrivaPath Diagnostics Limited
IE-MF-000045162 · Ireland · Dublin
PrivaPath Diagnostics Limited is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- LetsGetChecked Blood Home Sample Collection Kit
- LetsGetChecked Blood and Urine Home Sample Collection Kit
- LetsGetChecked Stool Home Sample Collection Kit
Catalogue references include BO06I, BO08I, BO11I, BO19I, BO20I, BO27I.
European nomenclature codes declared: W0501010299, W05019001, W05019099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Privapath Diagnostics Ltd (IE) · FDA 3015209536 |
| Devices in EUDAMED | 9 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 11.1 % |
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. PrivaPath Diagnostics Limited is registered in the United States but was not found in the Canadian register.