EU → North America Device Access

VITA Zahnfabrik H. Rauter GmbH & Co. KG

DE-MF-000005906 · Germany · Bad Säckingen

VITA Zahnfabrik H. Rauter GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 12 844 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa12 833
Class IIb11

Among these devices, 26 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 12 844 declared devices.

Catalogue references include A60M3O6L, A64L15X96, A6B3X99, A6C444CU, AWC4L40, B4544350.

European nomenclature codes declared: Q010699, P01020180, P01020101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. (DE) · FDA 1000625496
Devices in EUDAMED12 844
Country of registrationGermany

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryVITA ZAHNFABRIK, H. RAUTER GMBH & CO. KG

What it holds in Canada

Licences on record30
Currently active0
Class 2 devices4
Class 3 devices26
First licensed1999-06-08

Licence types: Device Family (19), System (6), Device Group Family (4), Single Device (1).

Licensed under: VITA VMLC PRIMER, PORCELAIN DENTURE TEETH AND PREFORMS, VITA AND CEREC BLOCS, VITA PORCELAIN POWDERS, VITA STAINS, ACRYLIC DENTURE TEETH.

North American profile: Both markets. VITA Zahnfabrik H. Rauter GmbH & Co. KG is registered in both the United States and Canada.

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