EU → North America Device Access

FotoFinder Systems GmbH

DE-MF-000007084 · Germany · Bad Birnbach

FotoFinder Systems GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Most frequent device types declared: 2026.1, 3.5, 6.1, FotoFinder medicam 1000.

Among these devices, 8 are declared active.

Devices declared under this manufacturer

Catalogue references include 1.9, 2.1, FFS001502, FFS010040, FFS013920, FFS720160.

European nomenclature codes declared: Z12040192, Z12040118.

United States market access

FDA establishment registerRegistered with FDA
Matched entryFOTOFINDER SYSTEMS GMBH (DE) · FDA 3004468424
Devices in EUDAMED8
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN8
Found in the U.S. device database2
Share25.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryFOTOFINDER SYSTEMS GMBH

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2024-01-16

Licence types: System (1).

Licensed under: FOTOFINDER BODYSTUDIO ATBM MASTER.

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

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