PRIMA Lab SA
CH-MF-000034473 · Switzerland · Morbio Inferiore
PRIMA Lab SA is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 100077-x, 800017-x, 800025-x, 800034-x, 800040-x.
Authorised representative in the Union: QbD RepS BV.
Devices declared under this manufacturer
- Barza AmnioTest
- Dr. Max Helicobacter pylori test
- Estromineral
- MyTest Celiachia
- Newfoundland Strep A Self-test
- PRIMA HOME TEST
- PROFAR STREP A TEST
- PROFAR Test PSA
- SANAVITA TEST Gravidanza - EARLY DETECTION PREGNANCY TEST
- SPERM TEST
- Test autodiagnostico Celiachia
- Veneris Test rapid HIV 1&2
Showing 12 of 45 declared devices.
Catalogue references include 100077-1CS, 100082-x, 300077, 801060-1, 801080, 880060-x.
European nomenclature codes declared: W01021111, W0102160302, W0102100602, W0102160399, W0105090302, W0101060204.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 45 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| 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 Lab SA was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1408400113 | supplemented | 2028-10-25 |