EU → North America Device Access

CareCare Oy

FI-MF-000017782 · Finland · Joensuu

CareCare Oy is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa35

Most frequent device types declared: CareCare IGS Pitosukka – XXS CareCare IGS Pitosukka – S CareCare IGS P, Kitkanauha – M Kitkanauha – XL Kitkanauha - Avaaja-Apu Kitkanauha - Li.

Devices declared under this manufacturer

Showing 12 of 35 declared devices.

Catalogue references include GS 01010S, GS 01010XL, GS 01050M, GSD 010010S, GSD 01002M, GSD 01050M.

European nomenclature codes declared: Y0999.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED35
Country of registrationFinland

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

Device-level evidence

Devices with a numeric GTIN35
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. CareCare Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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