EU → North America Device Access

TALARMADE

UK-MF-000048539 · United Kingdom · Chesterfield

TALARMADE is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Most frequent device types declared: AUPRNS, HUC.

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

Catalogue references include APRB/L, HUC, TM-DX/EU34/PR, TM-DX/EU36/PR, TM-DX/EU40/PR, TM-DX/EU44/PR.

European nomenclature codes declared: Y0699, Y060312.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
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 GTIN13
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. TALARMADE was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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