EU → North America Device Access

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

43 manufacturers registered in Slovakia with at least 5 devices declared in the European database. Of these, 38 were not found in the U.S. FDA establishment register, 3 were matched, and 2 have a similar name that needs checking.

Against the Canadian register, 42 of them were not found, 1 hold a Health Canada licence, and 0 need checking.

ManufacturerDevices FDAHealth Canada
Sky Medical a.s.1 422Registered with FDANot found in the Canadian register
EKOM spol. s r.o.922Registered with FDALicensed in Canada
Diawin s.r.o.825Not found in the FDA registerNot found in the Canadian register
MARTIKAN s.r.o.585Not found in the FDA registerNot found in the Canadian register
PROTETIKA, a.s.565Not found in the FDA registerNot found in the Canadian register
MATERASSO Slovakia, s.r.o.509Not found in the FDA registerNot found in the Canadian register
DB Biotech, a.s.360Not found in the FDA registerNot found in the Canadian register
Mirbachplus s.r.o.205Not found in the FDA registerNot found in the Canadian register
Ferno Slovakia201Similar name found — unverifiedNot found in the Canadian register
CHIRANA T.Injecta, a.s.97Registered with FDANot found in the Canadian register
Diagnostics s.r.o.83Not found in the FDA registerNot found in the Canadian register
Unimed Pharma spol. s r.o.81Not found in the FDA registerNot found in the Canadian register
VIDRA a spol. s.r.o.61Not found in the FDA registerNot found in the Canadian register
Lumatix s.r.o.56Not found in the FDA registerNot found in the Canadian register
Messer Tatragas, spol. s r.o.55Not found in the FDA registerNot found in the Canadian register
OXYWISE, s.r.o.45Not found in the FDA registerNot found in the Canadian register
Medexim, spol. s r.o.40Not found in the FDA registerNot found in the Canadian register
DIPLOMAT DENTAL s.r.o.39Not found in the FDA registerNot found in the Canadian register
WWW.KOMPRESS.SK, s.r.o.39Not found in the FDA registerNot found in the Canadian register
POSTHORAX s.r.o.34Similar name found — unverifiedNot found in the Canadian register
Chirana Progress, s.r.o.27Not found in the FDA registerNot found in the Canadian register
PANACEA, s.r.o.22Not found in the FDA registerNot found in the Canadian register
Herb-Pharma Corporation s.r.o.21Not found in the FDA registerNot found in the Canadian register
MEDIST, s.r.o.16Not found in the FDA registerNot found in the Canadian register
Mjartan, s. r. o.16Not found in the FDA registerNot found in the Canadian register
Poľnohospodárske družstvo "Radošinka"14Not found in the FDA registerNot found in the Canadian register
POWERFUL MEDICAL s.r.o.13Not found in the FDA registerNot found in the Canadian register
Aqvitox Technology, s.r.o.12Not found in the FDA registerNot found in the Canadian register
SKYDENT, a.s.11Not found in the FDA registerNot found in the Canadian register
EMG Care s.r.o.9Not found in the FDA registerNot found in the Canadian register
MAR´CO, s.r.o.8Not found in the FDA registerNot found in the Canadian register
Cord Blood Center Laboratories, s.r.o.7Not found in the FDA registerNot found in the Canadian register
Mlad s.r.o.7Not found in the FDA registerNot found in the Canadian register
PKP Bardejov s.r.o.7Not found in the FDA registerNot found in the Canadian register
UTAS Technologies7Not found in the FDA registerNot found in the Canadian register
VULM s.r.o.7Not found in the FDA registerNot found in the Canadian register
CHIROMEGA6Not found in the FDA registerNot found in the Canadian register
Nuovo Therapy s.r.o.6Not found in the FDA registerNot found in the Canadian register
TatraMed Software s.r.o.6Not found in the FDA registerNot found in the Canadian register
ACG Air & Gas Solutions SK s.r.o.5Not found in the FDA registerNot found in the Canadian register
Auguste Cryogenics Slovakia s.r.o.5Not found in the FDA registerNot found in the Canadian register
Michal Kačur TOPOR s. r. o.5Not found in the FDA registerNot found in the Canadian register
Trinity Healthcare Group a.s.5Not found in the FDA registerNot found in the Canadian register

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