EU → North America Device Access

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 IIa6

Most frequent device types declared: ABPMWebCor v. 1.y.z, BPCor v. 1.y.z, CER-S v. 4.y.z, ECGCor 1.y.z, RemoteCor v. 2.y.z.

Among these devices, 6 are declared active, 3 with a measuring function.

Devices declared under this manufacturer

Catalogue references include CCZ1205038206, CCZ1205048204, CCZ1205048205, CCZ1205048207, CCZ1205048208, CCZ1205908202.

European nomenclature codes declared: V92,Z12050482, V92, V92,Z12050382.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryCARDIOCALM SRL (IT) · FDA 3017840980
Devices in EUDAMED6
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryCARDIO CALM SRL

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2026-02-25

Licence types: Single Device (1).

Licensed under: CER-S.

Notified body certificates

CertificateStatusExpiry
ITH 1343804 1supplemented2027-04-21

Other manufacturers in Italy

All Italy manufacturers →