EU → US 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, 21 were not found in the U.S. FDA establishment register, 0 were matched, and 2 have a similar name that needs checking.

ManufacturerDevices FDA
Polident d.o.o. Industrija dentalnih proizvodov4 376Not found in the FDA register
INTERDENT proizvodnja in trgovina, d.o.o.592Not found in the FDA register
PURO TEHNIKA PODJETJE ZA PREDELAVO IN TRŽENJE P500Not found in the FDA register
KOVAL PROIZVODNJA IN TRGOVINA, D.O.O.135Not found in the FDA register
NOVAK M proizvodnja, trgovina in storitve d.o.o.84Not found in the FDA register
MAH OPORNICE Alojzija Hrovat s.p.73Not found in the FDA register
FOTONA, proizvodnja optoelektronskih naprav d.o.31Not found in the FDA register
Iskra Medical, d.o.o., raziskave in razvoj na po31Similar name found — unverified
Medicop - specialna oprema d.o.o.28Not found in the FDA register
Golias d.o.o.27Not found in the FDA register
HYB d.o.o.26Not found in the FDA register
TIMO d.o.o. Ajdovščina23Not found in the FDA register
Zlatarna Celje d.o.o.19Not found in the FDA register
Alcom d.o.o.17Not found in the FDA register
VITA CENTER D.O.O.14Not found in the FDA register
SIMPS'S podjetje za svetovanje, inženiring, mark13Not found in the FDA register
DOMEL, d.o.o.12Similar name found — unverified
ORTOSANA, PRODAJA IN SERVIS REHABILITACIJSKIH PR10Not found in the FDA register
SAN.KO.M. d.o.o.10Not found in the FDA register
ENIKAM d.o.o.7Not found in the FDA register
Alisa trgovina in storitve Alenka Stopar s.p.6Not found in the FDA register
Audax d.o.o.6Not found in the FDA register
ŽIKPLAST Žitnik Anja s.p.6Not found in the FDA register

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