EU → North America 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 IIa483
Class IIb491

Most frequent device types declared: Accessories for prothetic parts, Accessories implantology and oral surgery, Bur blocks and trays, Hand-held instruments dentistry, Oktagon Dental Implants.

Among these devices, 131 are declared sterile, 491 implantable, 32 reusable.

Devices declared under this manufacturer

Showing 12 of 974 declared devices.

Catalogue references include 22072, BL300 GEL, GS4, KAB25, MP33, OR622 GEL.

European nomenclature codes declared: P01020180, Q0199, P01020101, V0480, Q010280, P09120699.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHAGER & MEISINGER GMBH (DE) · FDA 8010516
Devices in EUDAMED974
Country of registrationGermany

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryHAGER & MEISINGER GMBH

What it holds in Canada

Licences on record18
Currently active0
Class 2 devices14
Class 3 devices4
First licensed2007-03-09

Licence types: System (7), Device Family (6), Device Group Family (3), Device Group (2).

Licensed under: TUNGSTEN CARBIDE BURS, DIAMOND INSTRUMENTS, FLEXIBLE POLISHERS, CERAMIC ABRASIVES, SURGICAL CUTTERS/SURGICAL BURS, LIFT-CONTROL BONE RAISING SYSTEM.

North American profile: Both markets. Hager & Meisinger GmbH is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
44911220651supplemented2029-03-06

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