EU → North America Device Access

Dreve Dentamid GmbH

DE-MF-000005452 · Germany · Unna

Dreve Dentamid GmbH is registered in the European database on medical devices as a manufacturer, with 311 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa311

Catalogue references include 1015120050, 1020120050, 2008120100, 2008125100, D3865, D42481SQ.

European nomenclature codes declared: Q010699, Q01020102, Q01020199, Q0102050101, Q010503.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDREVE DENTAMID GMBH (DE) · FDA 1000486347
Devices in EUDAMED311
Country of registrationGermany

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryDREVE DENTAMID GMBH

What it holds in Canada

Licences on record5
Currently active0
Class 2 devices5
First licensed2013-12-06

Licence types: Single Device (3), Device Family (2).

Licensed under: THERMOFORMING BLANKS, FOTODENT IBT, FOTODENT DENTURE, PRIMEPRINT DIRECT ALIGNER, NANOVARNISH.

North American profile: Both markets. Dreve Dentamid GmbH is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
44911220477supplemented2028-12-04

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