EU → North America Device Access

Impo International Limited

GB-MF-000010073 · United Kingdom · Greater London

Impo International Limited is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa108

Most frequent device types declared: GuardedSleep Absorbent Pad Range, Kedley Support & Compression Range.

Authorised representative in the Union: Eurolink Europe Compliance Limited.

Devices declared under this manufacturer

Showing 12 of 108 declared devices.

Catalogue references include AHW003, AHW013, KED002, KED031, KED062, KED067.

European nomenclature codes declared: T04010299, Y06120601, M0304010101, Y061209, Y060613, M04010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED108
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 GTIN108
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. Impo International Limited was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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