EU → North America Device Access

Topdental (Products) Ltd

GB-MF-000003937 · United Kingdom · Halifax

Topdental (Products) Ltd is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa30

Authorised representative in the Union: Directa AB.

Devices declared under this manufacturer

Showing 12 of 30 declared devices.

Catalogue references include 123-044, 2S03195, 518600, BOS9794, CBM9788, DIB137.

European nomenclature codes declared: D0801, Z12110185.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED30
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 GTIN28
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. Topdental (Products) Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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