EU → North America Device Access

Beurer GmbH

DE-MF-000005422 · Germany · Ulm

Beurer GmbH is registered in the European database on medical devices as a manufacturer, with 117 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa117

Most frequent device types declared: BC 87, BM 27, BR 60, FT 16, FT 65.

Among these devices, 109 are declared active, 53 with a measuring function.

Catalogue references include 10470, 45414, 45420, 60422, 60617, 60849.

European nomenclature codes declared: Z1203020501, R060101, Z129099, V0301010299, V0301010201, Z1203020408.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED117
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN116
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryBEURER GMBH

What it holds in Canada

Licences on record13
Currently active0
Class 2 devices12
Class 3 devices1
First licensed2010-04-20

Licence types: Device Family (9), Single Device (3), Device Group Family (1).

Licensed under: INFRARED THERMOMETER, INFRARED EAR THERMOMETER, ELECTRONIC THERMOMETER, NEBULIZER, BLOOD PRESSURE MONITORS, BODY ANALYSIS SCALES.

North American profile: Canada only. Beurer GmbH holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Germany

All Germany manufacturers →