EU → North America Device Access

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

18 manufacturers registered in Croatia with at least 5 devices declared in the European database. Of these, 17 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, 17 of them were not found, 0 hold a Health Canada licence, and 1 need checking.

ManufacturerDevices FDAHealth Canada
BioGnost Ltd.1 127Not found in the FDA registerSimilar name found — unverified
Lentismed d.o.o.290Not found in the FDA registerNot found in the Canadian register
Lola Ribar d.o.o. za proizvodnju saniteta242Not found in the FDA registerNot found in the Canadian register
DIAGONAL d.o.o. za trgovinu i usluge210Not found in the FDA registerNot found in the Canadian register
OTOS Ortopedska tehnika d.o.o.137Not found in the FDA registerNot found in the Canadian register
Awatar Medical Aid d.o.o.134Not found in the FDA registerNot found in the Canadian register
MOOR ORTOTIKA I PROTETIKA d.o.o. za izradu, dora106Not found in the FDA registerNot found in the Canadian register
Pamel d.o.o.104Registered with FDANot found in the Canadian register
Eonex d.o.o.66Not found in the FDA registerNot found in the Canadian register
Hrvatski zavod za transfuzijsku medicinu40Not found in the FDA registerNot found in the Canadian register
Instrumentaria d.d.35Not found in the FDA registerNot found in the Canadian register
SGM d.o.o.35Not found in the FDA registerNot found in the Canadian register
TERRAPROMO d.o.o. za trgovinu i usluge35Not found in the FDA registerNot found in the Canadian register
Vik Dental d.o.o.28Not found in the FDA registerNot found in the Canadian register
C-pharm d.o.o.27Not found in the FDA registerNot found in the Canadian register
Hamapharm d.o.o.25Not found in the FDA registerNot found in the Canadian register
Apipharma farmaceutsko-prehrambena, kozmetička i19Not found in the FDA registerNot found in the Canadian register
Medicline društvo s ograničenom odgovornošću za 7Not found in the FDA registerNot found in the Canadian register

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