EU → North America Device Access

to signify GmbH

DE-MF-000007024 · Germany · Halle (Saale)

to signify GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: Konnex 7.

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include Konnex 12, Konnex 12 Eye, Konnex 7, Konnex 7s, Konnex 9, Konnex 9s.

European nomenclature codes declared: Y214209.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. to signify GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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