EU → US Device Access

medesign I.C. GmbH

DE-MF-000020677 · Germany · Dietramszell

medesign I.C. GmbH is registered in the European database on medical devices as a manufacturer, with 374 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb204
Class IIa170

Most frequent device types declared: T-Pessar Typ B Ø 46 - Länge 81 mm, Vaginal Pessar rund-rund 35 x 80 mm, Cerclage-Pessar 32 / 70 / 25 mm, Würfel-Pessar Tandem Gr. 1 - 0 - Faden, Ladysoft Gleitgel 30 ml.

Among these devices, 1 are declared reusable, 1 active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED374
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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