EU → North America Device Access

IML Instrumenta Mechanik Labor System GmbH

DE-MF-000034869 · Germany · Wiesloch

IML Instrumenta Mechanik Labor System GmbH is registered in the European database on medical devices as a manufacturer, with 58 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa58

Most frequent device types declared: IML-Artikulator, IML-Gesichtsbogen.

Devices declared under this manufacturer

Showing 12 of 58 declared devices.

Catalogue references include 20110-218, 20110-326, 20210-126, 22110-118, 22210-118, 23210-116.

European nomenclature codes declared: Q010199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED58
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 GTIN58
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. IML Instrumenta Mechanik Labor System GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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