EU → North America Device Access

Ergotrics

BE-MF-000024176 · Belgium · Turnhout

Ergotrics is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa24

Most frequent device types declared: Covers, Hummingbird, Inflatable Board, Inflatable Multipurpose Roll, Inflatable Prone Support.

Devices declared under this manufacturer

Showing 12 of 24 declared devices.

Catalogue references include COV-PAU-nn, HMB-AAA-nn, IMC-HLD-nn, IMR-OSL-nn, IMR-WLL-nn, IPS-PUL-nn.

European nomenclature codes declared: Z12011285, Z12011280, Z12011299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED24
Country of registrationBelgium

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

Device-level evidence

Devices with a numeric GTIN24
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. Ergotrics was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

All Belgium manufacturers →