EU → North America Device Access

InfinetaMed AG

CH-MF-000045034 · Switzerland · Sarnen

InfinetaMed AG is registered in the European database on medical devices as a manufacturer, with 87 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb56
Class IIa31

Among these devices, 44 are declared sterile, 56 implantable.

Authorised representative in the Union: MedNet EC-REP IIb GmbH.

Devices declared under this manufacturer

Showing 12 of 87 declared devices.

Catalogue references include 111.4313, 122.5540, 131.2832, 131.3842, 162.0100, 172.0100.

European nomenclature codes declared: P01020180, P01020101, S0199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryINFINETAMED AG (CH) · FDA 3038549074
Devices in EUDAMED87
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN87
Found in the U.S. device database25
Share28.7 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryINFINETAMED AG

What it holds in Canada

Licences on record5
Currently active0
Class 2 devices1
Class 3 devices4
First licensed2025-10-15

Licence types: Device Family (3), System (1), Device Group Family (1).

Licensed under: NUVENTUS NV.C DENTAL DRILLS AND DENTAL INSTRUM, NUVENTUS NV.C DENTAL IMPLANTS, NUVENTUS NV.C TEMPORARY PROSTHETIC COMPONENTS, NUVENTUS NV.C HEALING COMPONENTS (PROSTHETIC C, NUVENTUS NV.C MULTI-UNIT ABUTMENTS COMPONENTS.

North American profile: Both markets. InfinetaMed AG is registered in both the United States and Canada.

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