EU → North America Device Access

MDT Int'l SA

CH-MF-000028146 · Switzerland · Geneva

MDT Int'l SA is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I6
Class IIa1

Most frequent device types declared: M112D101T, M121D101T, M211D000T, M301D002T, M311D000T.

Among these devices, 5 are declared sterile, 5 implantable, 1 active.

Authorised representative in the Union: QbD RepS BV.

Devices declared under this manufacturer

Catalogue references include M112D101T, M121D101T, M211D000T, M301D002T, M311D000T, M501D000T.

European nomenclature codes declared: P9099, G05.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationSwitzerland

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

Device-level evidence

Devices with a numeric GTIN7
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMDT INT'L SA

What it holds in Canada

Licences on record1
Currently active0
Class 3 devices1
First licensed2020-11-04

Licence types: Single Device (1).

Licensed under: SPORTVIS.

North American profile: Canada only. MDT Int'l SA holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Switzerland

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