EU → North America Device Access

IBIS Srl

IT-MF-000024698 · Italy · Bergamo

IBIS Srl is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb10

Among these devices, 10 are declared active.

Devices declared under this manufacturer

Catalogue references include 01.15.003.001, 01.15.005.001, 01.15.016.001, 01.15.017.001, 01.15.027.001, 01.18.013.001.

European nomenclature codes declared: Z11039016, Z11039017.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. IBIS Srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
159/MDRsupplemented2029-03-05

Other manufacturers in Italy

All Italy manufacturers →