CARDIOLINE SpA
IT-MF-000029682 · Italy · TRENTO
CARDIOLINE SpA is registered in the European database on medical devices as a manufacturer, with 129 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 129 |
|---|
Among these devices, 129 are declared active, 80 with a measuring function.
Catalogue references include 63050107, 63050131, 63050152, 63050164, KSSMPCTL0-SL, KTCH30000-A.
European nomenclature codes declared: Z12050302, Z12050380, Z12050101, Z12050301, Z12059009, Z12050403.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | Cardioline S.P.A. (IT) · FDA 3009735945 |
| Devices in EUDAMED | 129 |
| Country of registration | Italy |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 129 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 3.9 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1343191 1 | supplemented | 2029-10-20 |