EU → North America Device Access

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

23 manufacturers registered in Slovenia with at least 5 devices declared in the European database. Of these, 23 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, 23 of them were not found, 0 hold a Health Canada licence, and 0 need checking.

ManufacturerDevices FDAHealth Canada
Polident d.o.o. Industrija dentalnih proizvodov4 376Not found in the FDA registerNot found in the Canadian register
INTERDENT proizvodnja in trgovina, d.o.o.592Not found in the FDA registerNot found in the Canadian register
PURO TEHNIKA PODJETJE ZA PREDELAVO IN TRŽENJE P500Not found in the FDA registerNot found in the Canadian register
KOVAL PROIZVODNJA IN TRGOVINA, D.O.O.135Not found in the FDA registerNot found in the Canadian register
NOVAK M proizvodnja, trgovina in storitve d.o.o.84Not found in the FDA registerNot found in the Canadian register
MAH OPORNICE Alojzija Hrovat s.p.73Not found in the FDA registerNot found in the Canadian register
FOTONA, proizvodnja optoelektronskih naprav d.o.31Not found in the FDA registerNot found in the Canadian register
Iskra Medical, d.o.o., raziskave in razvoj na po31Not found in the FDA registerNot found in the Canadian register
Medicop - specialna oprema d.o.o.28Not found in the FDA registerNot found in the Canadian register
Golias d.o.o.27Not found in the FDA registerNot found in the Canadian register
HYB d.o.o.26Not found in the FDA registerNot found in the Canadian register
TIMO d.o.o. Ajdovščina23Not found in the FDA registerNot found in the Canadian register
Zlatarna Celje d.o.o.19Not found in the FDA registerNot found in the Canadian register
Alcom d.o.o.17Not found in the FDA registerNot found in the Canadian register
VITA CENTER D.O.O.14Not found in the FDA registerNot found in the Canadian register
SIMPS'S podjetje za svetovanje, inženiring, mark13Not found in the FDA registerNot found in the Canadian register
DOMEL, d.o.o.12Not found in the FDA registerNot found in the Canadian register
ORTOSANA, PRODAJA IN SERVIS REHABILITACIJSKIH PR10Not found in the FDA registerNot found in the Canadian register
SAN.KO.M. d.o.o.10Not found in the FDA registerNot found in the Canadian register
ENIKAM d.o.o.7Not found in the FDA registerNot found in the Canadian register
Alisa trgovina in storitve Alenka Stopar s.p.6Not found in the FDA registerNot found in the Canadian register
Audax d.o.o.6Not found in the FDA registerNot found in the Canadian register
ŽIKPLAST Žitnik Anja s.p.6Not found in the FDA registerNot found in the Canadian register

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