EU → North America Device Access

Medical device manufacturers in Austria and the U.S. market

79 manufacturers registered in Austria with at least 5 devices declared in the European database. Of these, 53 were not found in the U.S. FDA establishment register, 24 were matched, and 2 have a similar name that needs checking.

Against the Canadian register, 69 of them were not found, 9 hold a Health Canada licence, and 1 need checking.

ManufacturerDevices FDAHealth Canada
Dendia GmbH2 264Not found in the FDA registerNot found in the Canadian register
Natur Vital Handels GmbH927Not found in the FDA registerNot found in the Canadian register
Amann Girrbach AG810Registered with FDALicensed in Canada
Moltoplast GmbH559Not found in the FDA registerNot found in the Canadian register
W & H Dentalwerk Bürmoos GmbH452Similar name found — unverifiedSimilar name found — unverified
GANTER Shoes GmbH434Not found in the FDA registerNot found in the Canadian register
edelweiss dentistry products gmbh413Registered with FDANot found in the Canadian register
Technoclone Herstellung von Diagnostika und Arzn320Not found in the FDA registerNot found in the Canadian register
Falcon Medical Medizinische Spezialprodukte GmbH314Not found in the FDA registerNot found in the Canadian register
Syncro Med Orthopädische Erzeugnisse GmbH314Not found in the FDA registerNot found in the Canadian register
Greiner Bio-One GmbH296Registered with FDALicensed in Canada
BHM-Tech Produktionsgesellschaft m.b.H.186Registered with FDANot found in the Canadian register
CARL REINER GmbH Medizintechnik für Diagnose und175Not found in the FDA registerNot found in the Canadian register
MED TRUST Handelsges.m.b.H.150Not found in the FDA registerNot found in the Canadian register
Leonhard Lang GmbH144Registered with FDALicensed in Canada
METASYS Medizintechnik GmbH144Not found in the FDA registerNot found in the Canadian register
NEVEON Austria GmbH143Not found in the FDA registerNot found in the Canadian register
IT-V Medizintechnik GmbH132Registered with FDANot found in the Canadian register
Medgas Technik medical systems GmbH90Not found in the FDA registerNot found in the Canadian register
Fittydent International GmbH66Not found in the FDA registerNot found in the Canadian register
EC Certification Service GmbH63Registered with FDANot found in the Canadian register
KOSAN PHARMA GmbH54Not found in the FDA registerNot found in the Canadian register
Kunststoffwerk Kremsmünster GmbH49Not found in the FDA registerNot found in the Canadian register
THI Total Healthcare Innovation GmbH43Registered with FDANot found in the Canadian register
iSYS Medizintechnik GmbH36Registered with FDANot found in the Canadian register
Websinger Gesellschaft m.b.H.36Not found in the FDA registerNot found in the Canadian register
EUROLyser Diagnostica GmbH26Not found in the FDA registerNot found in the Canadian register
GE Healthcare Austria GmbH & Co OG26Registered with FDALicensed in Canada
KLAXON MOBILITY GmbH26Registered with FDANot found in the Canadian register
APrevent Biotech GmbH25Not found in the FDA registerNot found in the Canadian register
Hagleitner Hygiene International GmbH24Not found in the FDA registerNot found in the Canadian register
room4 Softwareentwicklung GmbH24Not found in the FDA registerNot found in the Canadian register
Rudolf Heintel Gesellschaft m.b.H.24Not found in the FDA registerNot found in the Canadian register
"Gamma" Medizinisch-wissenschaftliche Fortbildun23Similar name found — unverifiedNot found in the Canadian register
A.M.I. Agency for Medical Innovations GmbH23Registered with FDALicensed in Canada
ARCHImedline GmbH23Not found in the FDA registerNot found in the Canadian register
Bugslock GmbH23Not found in the FDA registerNot found in the Canadian register
MSP Medizintechnik GmbH23Not found in the FDA registerNot found in the Canadian register
Cube Dx GmbH20Not found in the FDA registerNot found in the Canadian register
BANO Healthcare GmbH15Not found in the FDA registerNot found in the Canadian register
SteadySense GmbH15Registered with FDANot found in the Canadian register
surgebright GmbH15Registered with FDANot found in the Canadian register
Tyromotion GmbH15Registered with FDALicensed in Canada
AIT Austrian Institute of Technology GmbH14Registered with FDANot found in the Canadian register
contextflow GmbH14Not found in the FDA registerNot found in the Canadian register
RIVIERA Pharma & Cosmetics GmbH14Not found in the FDA registerNot found in the Canadian register
JOANNEUM RESEARCH Forschungsgesellschaft mbH13Not found in the FDA registerNot found in the Canadian register
Optik Sutter e.U.13Not found in the FDA registerNot found in the Canadian register
P.G.F. Industry Solutions GmbH13Registered with FDANot found in the Canadian register
Wolfgang Radner12Not found in the FDA registerNot found in the Canadian register
DEZIMAL GmbH11Not found in the FDA registerNot found in the Canadian register
Saphenus Medical technology GmbH11Not found in the FDA registerNot found in the Canadian register
Pharmazeutische Fabrik Montavit Ges.m.b.H.10Registered with FDANot found in the Canadian register
Messer Austria GmbH9Not found in the FDA registerNot found in the Canadian register
Rosa Toifl & Co GmbH9Not found in the FDA registerNot found in the Canadian register
Textilservice Brolli GesmbH9Not found in the FDA registerNot found in the Canadian register
Hofer GmbH & Co KG8Not found in the FDA registerNot found in the Canadian register
Physiotechnik Schaffarik GmbH8Not found in the FDA registerNot found in the Canadian register
BHS Technologies GmbH7Not found in the FDA registerNot found in the Canadian register
Colenta Labortechnik GmbH & Co KG7Not found in the FDA registerNot found in the Canadian register
decide Clinical Software GmbH7Not found in the FDA registerNot found in the Canadian register
EMS Handels Gesellschaft m.b.H.7Registered with FDANot found in the Canadian register
Humanomed IT Solutions GmbH7Not found in the FDA registerNot found in the Canadian register
SAMINA Produktions- und Handels GmbH7Not found in the FDA registerNot found in the Canadian register
24sens6Not found in the FDA registerNot found in the Canadian register
Derma Medical Systems6Not found in the FDA registerNot found in the Canadian register
g.tec medical engineering GmbH6Registered with FDALicensed in Canada
GENSPEED Biotech6Not found in the FDA registerNot found in the Canadian register
IB Lab GmbH6Registered with FDANot found in the Canadian register
medaia GmbH6Not found in the FDA registerNot found in the Canadian register
medPhoton GmbH6Registered with FDALicensed in Canada
Otto Bock Healthcare Products GmbH6Registered with FDALicensed in Canada
Sano Transportgeraete GmbH6Registered with FDANot found in the Canadian register
Theresienoil GmbH6Not found in the FDA registerNot found in the Canadian register
Pansatori GmbH5Not found in the FDA registerNot found in the Canadian register
Photonic Optische Geräte GesmbH&CoKG5Not found in the FDA registerNot found in the Canadian register
synedra information technologies GmbH5Not found in the FDA registerNot found in the Canadian register
T-Systems Austria GesmbH5Not found in the FDA registerNot found in the Canadian register
XUND Solutions GmbH5Not found in the FDA registerNot found in the Canadian register

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