EU → North America Device Access

Talkingeyes & More GmbH

DE-MF-000010488 · Germany · Erlangen

Talkingeyes & More GmbH is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa12

Most frequent device types declared: MedStage.

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Catalogue references include 1, 11, 12, 13, 19.10.2.1, 20240516.

European nomenclature codes declared: Z1399, Y0599, Z12069092.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
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 GTIN5
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. Talkingeyes & More GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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