CARDIO CALM S.R.L.
IT-MF-000017950 · Italy · Montichiari
CARDIO CALM S.R.L. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: CER-S v. 4.y.z, ABPMWebCor v. 1.y.z, RemoteCor v. 2.y.z, BPCor v. 1.y.z, ECGCor 1.y.z.
Among these devices, 6 are declared active, 3 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | CARDIOCALM SRL (IT) · FDA 3017840980 |
| Devices in EUDAMED | 6 |
| Country of registration | Italy |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1343804 1 | supplemented | 2027-04-21 |