EU → US Device Access

Dermaroller GmbH

DE-MF-000005021 · Germany · Wolfenbüttel

Dermaroller GmbH is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa13

Among these devices, 13 are declared sterile.

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 registerRegistered with FDA
Matched entryDermaroller GmbH (DE) · FDA 3007361698
Devices in EUDAMED13
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
6191GB449250723supplemented2028-09-02

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