EU → North America Device Access

Serchem Ltd

GB-MF-000004893 · United Kingdom · Telford

Serchem Ltd is registered in the European database on medical devices as a manufacturer, with 152 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa152

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 152 declared devices.

Catalogue references include 104320, 10591i, 1065U, 10902i, 1092P, K1090.

European nomenclature codes declared: D0801,D0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED152
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 GTIN152
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. Serchem Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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