EU → North America Device Access

MONDOTTICA LIMITED

GB-MF-000018978 · United Kingdom · NOTTINGHAM

MONDOTTICA LIMITED is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa7

Authorised representative in the Union: MYM SOPORTE TECNICO Y DE CALIDAD, S.L..

Devices declared under this manufacturer

Catalogue references include BEKO201620045, BEO309041654, BEO310341651, CL114204150, HEK132200255, TB1789501+1.548.

European nomenclature codes declared: Q02100203, Q0210030299, Q02100201, Q02100202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMONDOTTICA LTD (GB) · FDA 3005186804
Devices in EUDAMED7
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN7
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: United States only. MONDOTTICA LIMITED is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →