EU → North America Device Access

Colibris Eyewear GmbH

DE-MF-000025021 · Germany · Stockelsdorf

Colibris Eyewear GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Most frequent device types declared: ACE-K, ACE3D-K, ACEMETAL-K, STEEL-K, STEELRIM-K.

Devices declared under this manufacturer

Catalogue references include ACE-K, ACE3D-K, ACEMETAL-K, STEEL-K, STEELRIM-K, TITAN-K.

European nomenclature codes declared: Q02100201, Q02100202, Q02100203.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. Colibris Eyewear GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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