EU → North America Device Access

Urathon Europe Limited

UK-MF-000039685 · United Kingdom · Hilmarton

Urathon Europe Limited is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa24

Most frequent device types declared: 90398, 90653, 90682, 90704, 90705.

Authorised representative in the Union: Ives MD EU Rep Ltd.

Devices declared under this manufacturer

Showing 12 of 24 declared devices.

Catalogue references include 90209 AP, 90303, 90398, 90656, 90657, 90683.

European nomenclature codes declared: Y120699, Y091203, Y093303, Y120680.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED24
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 GTIN22
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. Urathon Europe Limited was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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