EU → US Device Access

MEDEALIS GmbH

DE-MF-000019555 · Germany · Abtsteinach

MEDEALIS GmbH is registered in the European database on medical devices as a manufacturer, with 114 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa78
Class IIb36

Most frequent device types declared: Accessories for prosthetic restoration, Straight Dental Abutment , Angled Dental Abutment 18°, Instrument, Dental Abutment Screw.

Among these devices, 36 are declared implantable, 5 reusable.

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 entryMEDEALIS GMBH (DE) · FDA 3017064961
Devices in EUDAMED114
Country of registrationGermany

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