EU → North America Device Access

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

8 manufacturers registered in Latvia with at least 5 devices declared in the European database. Of these, 7 were not found in the U.S. FDA establishment register, 1 were matched, and 0 have a similar name that needs checking.

Against the Canadian register, 7 of them were not found, 1 hold a Health Canada licence, and 0 need checking.

ManufacturerDevices FDAHealth Canada
TONUS ELAST SIA2 214Not found in the FDA registerNot found in the Canadian register
Ceram Optec SIA185Registered with FDALicensed in Canada
AGM orthopaedics58Not found in the FDA registerNot found in the Canadian register
Elvika55Not found in the FDA registerNot found in the Canadian register
Liepājas speciālās ekonomiskās zonas SIA Lauma M17Not found in the FDA registerNot found in the Canadian register
Liepājas Speciālās ekonomiskās zonas SIA NordePl12Not found in the FDA registerNot found in the Canadian register
SIA Laboveritas11Not found in the FDA registerNot found in the Canadian register
Latvia MGI Tech9Not found in the FDA registerNot found in the Canadian register

Other countries