EU → North America Device Access

HD Rehab AB

SE-MF-000005553 · Sweden · Lidingö

HD Rehab AB is registered in the European database on medical devices as a manufacturer, with 134 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa134

Among these devices, 134 are declared active.

Devices declared under this manufacturer

Showing 12 of 134 declared devices.

Catalogue references include 34011-1, 35051-0, 35051-3, 60265-6, 60315-6, 60418-6.

European nomenclature codes declared: Y122103, Y122106.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED134
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 GTIN134
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. HD Rehab AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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