EU → North America Device Access

JedX Medcare

FI-MF-000033367 · Finland · 01640

JedX Medcare is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: JedX 3614 W FT HLVP, JedX 3971 W FT HL, JedX 3972 W FT HL, Respirator mask.

Devices declared under this manufacturer

Catalogue references include 1351 W, 3614 PW, 3805 PW, 3971 W, 3972 W.

European nomenclature codes declared: T020604.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. JedX Medcare was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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