EU → North America Device Access

SC International Ltd

UK-MF-000047889 · United Kingdom · London

SC International Ltd is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Most frequent device types declared: Emergency Evacuation Sled/Mattress, Manual Evacuation Chair, Powered Evacuation Chair.

Authorised representative in the Union: Alchemy Holding B.V..

Devices declared under this manufacturer

Catalogue references include EV2000, EV3000, EV4000, EV5000, EV7000, SC-PRO-EMS-H.

European nomenclature codes declared: Y1899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. SC International Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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