EU → North America Device Access

Igloo Survival Limited

UK-MF-000045647 · United Kingdom · Bangor, Gwynedd, Wales

Igloo Survival Limited is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa11

Authorised representative in the Union: Reliance Medical (Ireland).

Devices declared under this manufacturer

Catalogue references include IG001, IG003, IG004, IG008, IG009, IG010.

European nomenclature codes declared: T030399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryIGLOO SURVIVAL LTD. (GB) · FDA 3042152186
Devices in EUDAMED11
Country of registrationUnited Kingdom

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: United States only. Igloo Survival Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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