EU → North America Device Access

Maltron International Ltd

GB-MF-000028357 · United Kingdom · Essex

Maltron International Ltd is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: MT950.

Among these devices, 5 are declared with a measuring function.

Authorised representative in the Union: Advena Limited.

Catalogue references include MT950.

European nomenclature codes declared: Z12099001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationUnited Kingdom

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

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMALTRON INTERNATIONAL LTD.

North American profile: Canada only. Maltron International Ltd holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →