EU → North America Device Access

Hengst SE

DE-MF-000006819 · Germany · Münster

Hengst SE is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Most frequent device types declared: Medizinische Gesichtsmaske.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 11086310000, 11088-318-000, 11090310000, 11106310000, 9416318000, 9515318000.

European nomenclature codes declared: T020604.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
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 GTIN13
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. Hengst SE was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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