EU → North America Device Access

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

31 manufacturers registered in Norway with at least 5 devices declared in the European database. Of these, 23 were not found in the U.S. FDA establishment register, 7 were matched, and 1 have a similar name that needs checking.

Against the Canadian register, 26 of them were not found, 5 hold a Health Canada licence, and 0 need checking.

ManufacturerDevices FDAHealth Canada
Klaveness Footwear AS7 095Not found in the FDA registerNot found in the Canadian register
Aprikos Medical AS4 333Not found in the FDA registerNot found in the Canadian register
Eurosko Gruppen AS939Not found in the FDA registerNot found in the Canadian register
Laerdal Medical AS263Similar name found — unverifiedLicensed in Canada
Glamox AS91Not found in the FDA registerNot found in the Canadian register
Medistim ASA88Registered with FDALicensed in Canada
Topro Industri AS87Not found in the FDA registerNot found in the Canadian register
Saga Dental Supply AS79Registered with FDANot found in the Canadian register
Granberg AS75Not found in the FDA registerNot found in the Canadian register
Oslo universitetssykehus HF73Not found in the FDA registerNot found in the Canadian register
Norgesplaster AS58Not found in the FDA registerNot found in the Canadian register
SERO AS52Registered with FDANot found in the Canadian register
GE Vingmed Ultrasound AS46Registered with FDALicensed in Canada
Bedtime AS19Not found in the FDA registerNot found in the Canadian register
Made for Movement Group AS19Registered with FDANot found in the Canadian register
NordicNeuroLab AS19Registered with FDALicensed in Canada
Somamed AS19Not found in the FDA registerNot found in the Canadian register
Appsens AS17Not found in the FDA registerNot found in the Canadian register
Ergo Contech16Not found in the FDA registerNot found in the Canadian register
Gentian AS16Registered with FDALicensed in Canada
Cypromed AS13Not found in the FDA registerNot found in the Canadian register
Calpro AS10Not found in the FDA registerNot found in the Canadian register
Ergoseat AS9Not found in the FDA registerNot found in the Canadian register
Lilleborg AS9Not found in the FDA registerNot found in the Canadian register
Wilhelmsen Chemicals AS8Not found in the FDA registerNot found in the Canadian register
EpiGuard AS7Not found in the FDA registerNot found in the Canadian register
Global Health Technology AS7Not found in the FDA registerNot found in the Canadian register
Maxeta AS6Not found in the FDA registerNot found in the Canadian register
Baldertech AS5Not found in the FDA registerNot found in the Canadian register
Innovolve AS5Not found in the FDA registerNot found in the Canadian register
RESPINOR AS5Not found in the FDA registerNot found in the Canadian register

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