EU → North America Device Access

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

10 manufacturers registered in Bulgaria with at least 5 devices declared in the European database. Of these, 9 were not found in the U.S. FDA establishment register, 0 were matched, and 0 have a similar name that needs checking.

Against the Canadian register, 9 of them were not found, 0 hold a Health Canada licence, and 0 need checking.

ManufacturerDevices FDAHealth Canada
Medtex Swiss Ltd590Not found in the FDA registerNot found in the Canadian register
Sopharma AD195Not found in the FDA registerNot found in the Canadian register
Momina krepost PLC35Not found in the FDA registerNot found in the Canadian register
ЖИВАС ООД24Name not comparable—
AMS OOD19Not found in the FDA registerNot found in the Canadian register
STS Medical Group AD15Not found in the FDA registerNot found in the Canadian register
NEW STYLE13Not found in the FDA registerNot found in the Canadian register
PPS MANUFACTURING10Not found in the FDA registerNot found in the Canadian register
KENTAMED Ltd.5Not found in the FDA registerNot found in the Canadian register
NIPI-M AD5Not found in the FDA registerNot found in the Canadian register

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