EU → North America Device Access

Caretec i Forserum AB

SE-MF-000036038 · Sweden · Forserum

Caretec i Forserum AB is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa26

Most frequent device types declared: Lyftbåge HCH Kpl P2 Krom, Lyftbåge kpl P2/P3 krom., Magne 120cm sängryggstöd, Magne 90cm sängryggstöd, Magne105cm sängryggstöd.

Among these devices, 21 are declared active.

Devices declared under this manufacturer

Showing 12 of 26 declared devices.

Catalogue references include 20255, 410600, 7002001001, 710398, 713023, 800000.

European nomenclature codes declared: Y121821, V08068099, Y1803, V08050103, V08068002, Y1299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED26
Country of registrationSweden

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN26
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. Caretec i Forserum AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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