EU → North America Device Access

ASEP HEALTHCARE LTD

GB-MF-000016192 · United Kingdom · Liverpool

ASEP HEALTHCARE LTD is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa25

Most frequent device types declared: Tournistretch, Tournistrip.

Authorised representative in the Union: Obelis s.a..

Devices declared under this manufacturer

Showing 12 of 25 declared devices.

Catalogue references include 43451TPEO/ASEP100, 43451TPEOM/ASEP25, 43451TPEOS/ASEP100, 43451TPEOS/ASEP25, 5080LS692/BRNM150, 5080LS692DB/ASEP150.

European nomenclature codes declared: V9003.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED25
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 GTIN25
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. ASEP HEALTHCARE LTD was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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