EU → North America Device Access

i.com medical GmbH

DE-MF-000008660 · Germany · München

i.com medical GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb11

Most frequent device types declared: HA Eye Drops Family.

Among these devices, 11 are declared sterile.

Devices declared under this manufacturer

Catalogue references include 4039869010017, 4039869010222, 4039869010314, 4039869011014, 4039869011113, 4039869011212.

European nomenclature codes declared: Q0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. i.com medical GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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