EU → US Device Access

Hager & Meisinger GmbH

DE-MF-000004966 · Germany · Neuss

Hager & Meisinger GmbH is registered in the European database on medical devices as a manufacturer, with 974 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb491
Class IIa483

Most frequent device types declared: Prosthetic abutment systems, Accessories implantology and oral surgery, Bur blocks and trays, Oktagon Dental Implants, Accessories for prothetic parts.

Among these devices, 131 are declared sterile, 491 implantable, 32 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 entryHAGER & MEISINGER GMBH (DE) · FDA 8010516
Devices in EUDAMED974
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
44911220651supplemented2029-03-06

Other manufacturers in Germany

All Germany manufacturers →