EU → North America Device Access

Jaeger Medical GmbH

DE-MF-000007090 · Germany · Hoechberg

Jaeger Medical GmbH is registered in the European database on medical devices as a manufacturer, with 150 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa150

Among these devices, 5 are declared active, 3 with a measuring function.

Catalogue references include 36-ASS1091, 892121, V-178603, V-707175, V-707779, V-821555.

European nomenclature codes declared: Z12159085, Z12159080, Z12159099, Z12159082, R049001.

United States market access

FDA establishment registerRegistered with FDA
Matched entryJaeger Medical GmbH (DE) · FDA 9615102
Devices in EUDAMED150
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN150
Found in the U.S. device database121
Share80.7 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryJAEGER MEDICAL GMBH

What it holds in Canada

Licences on record14
Currently active0
Class 2 devices14
First licensed2000-07-28

Licence types: Single Device (6), Device Family (5), System (2), Device Group (1).

Licensed under: VMAX SERIES, PULMONARY FUNCTION TESTER, AEROSOL PROVOCATION SYSTEM, RESPIRATORY PRESSURE MONITOR, MICROLAB SPIROMETER, MICROLOOP SPIROMETER.

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

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