EU → North America Device Access

iMEDgine GmbH

DE-MF-000019865 · Germany · Lichtenfels

iMEDgine GmbH is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa21

Most frequent device types declared: handscupe paresis, handscupe rheumatism.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include HS-RH-L-LI, HS-RH-S-LI, HS-RH-XL-LI, HS-RH-XS-RE, S-2121-00-PA, XL-5120-00-PA.

European nomenclature codes declared: Y241899, Y060613.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN21
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. iMEDgine GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →