EU → US Device Access

Cosinuss GmbH

DE-MF-000006937 · Germany · Munich

Cosinuss GmbH is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa20
Class IIb5

Most frequent device types declared: MSxx, MCxx, RCxx, DS02, DC02.

Among these devices, 19 are declared active, 17 with a measuring function.

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 EUDAMED25
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.

Notified body certificates

CertificateStatusExpiry
G15 101625 0004supplemented2028-02-01

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