EU → North America Device Access

ALTATEC GmbH

DE-MF-000006230 · Germany · Wimsheim

ALTATEC GmbH is registered in the European database on medical devices as a manufacturer, with 1 916 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb1 085
Class IIa831

Among these devices, 986 are declared sterile, 1 085 implantable, 26 reusable.

Devices declared under this manufacturer

Showing 12 of 1 916 declared devices.

Catalogue references include C2232.4315, C4007.1600, CA2011.3340, J4009.1627, J5074.3316, J5076.3309.

European nomenclature codes declared: P01020180, Z12110102, Z12110180, P01020101, L150101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryALTATEC GMBH (DE) · FDA 9613866
Devices in EUDAMED1 916
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN1 916
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryALTATEC GMBH

What it holds in Canada

Licences on record5
Currently active0
Class 3 devices5
First licensed2009-04-28

Licence types: System (4), Device Family (1).

Licensed under: CAMLOG IMPLANT SYSTEM, BASES FOR BAR ABUTMENT, GOLD, CAMLOG VARIO SR PROSTHETIC COMPONENTS SYSTEM, CONELOG IMPLANT SYSTEM, CONELOG PROGRESSIVE-LINE IMPLANT SYSTEM.

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

Notified body certificates

CertificateStatusExpiry
G11 076870 0021amended2026-06-23
D1063900002issued2031-06-24

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