EU → North America Device Access

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

97 manufacturers registered in Czechia with at least 5 devices declared in the European database. Of these, 85 were not found in the U.S. FDA establishment register, 12 were matched, and 0 have a similar name that needs checking.

Against the Canadian register, 93 of them were not found, 4 hold a Health Canada licence, and 0 need checking.

ManufacturerDevices FDAHealth Canada
MAXIS a.s.10 925Not found in the FDA registerNot found in the Canadian register
BEZNOSKA, s.r.o.3 481Not found in the FDA registerNot found in the Canadian register
MEDIN, a.s.2 342Not found in the FDA registerNot found in the Canadian register
Syntropiq s.r.o.2 323Not found in the FDA registerNot found in the Canadian register
LIPOELASTIC a.s.1 742Registered with FDANot found in the Canadian register
ARIES, a.s.1 666Not found in the FDA registerNot found in the Canadian register
DZO s.r.o.936Not found in the FDA registerNot found in the Canadian register
MAJOR CZ s.r.o.896Not found in the FDA registerNot found in the Canadian register
CLINITEX s.r.o.825Not found in the FDA registerNot found in the Canadian register
L I N E T spol. s r.o.650Registered with FDALicensed in Canada
Balerina-Czech, s.r.o.611Not found in the FDA registerNot found in the Canadian register
LASAK s.r.o.593Registered with FDANot found in the Canadian register
STERIWUND spol. s r.o.557Not found in the FDA registerNot found in the Canadian register
ORTEX , spol. s r.o.478Not found in the FDA registerNot found in the Canadian register
PANOP CZ s.r.o.436Not found in the FDA registerNot found in the Canadian register
BATIST Medical Productions s.r.o.354Not found in the FDA registerNot found in the Canadian register
ProSpon, spol. s r.o.264Not found in the FDA registerNot found in the Canadian register
GAMA GROUP a.s.259Not found in the FDA registerNot found in the Canadian register
VIDIA spol. s r.o.213Not found in the FDA registerNot found in the Canadian register
GeneProof a.s.211Not found in the FDA registerNot found in the Canadian register
PANEP s.r.o.202Not found in the FDA registerNot found in the Canadian register
VUP Medical, a.s.201Not found in the FDA registerNot found in the Canadian register
BIOSTER, a.s.189Not found in the FDA registerNot found in the Canadian register
Espeon, s.r.o.178Not found in the FDA registerNot found in the Canadian register
MZ Liberec, a.s.171Not found in the FDA registerNot found in the Canadian register
VIAMAR INTERNATIONAL, s.r.o.164Not found in the FDA registerNot found in the Canadian register
MEDILAB ČR s.r.o.134Not found in the FDA registerNot found in the Canadian register
Dr. Müller Pharma s.r.o.121Not found in the FDA registerNot found in the Canadian register
Erba Lachema s.r.o.113Not found in the FDA registerNot found in the Canadian register
IMMUNOTECH s.r.o.93Registered with FDALicensed in Canada
BATIST Medical a.s.90Not found in the FDA registerNot found in the Canadian register
Josef Nehonský85Not found in the FDA registerNot found in the Canadian register
Volter s.r.o.85Not found in the FDA registerNot found in the Canadian register
BSV Kubiš, s.r.o.82Not found in the FDA registerNot found in the Canadian register
AV Medical CZ s.r.o.75Not found in the FDA registerNot found in the Canadian register
ALFA VITA, s.r.o.74Not found in the FDA registerNot found in the Canadian register
RQL s.r.o.74Not found in the FDA registerNot found in the Canadian register
VULKAN - Medical, a.s.64Not found in the FDA registerNot found in the Canadian register
ADM, a.s.63Registered with FDANot found in the Canadian register
Ecomodi s.r.o.63Not found in the FDA registerNot found in the Canadian register
SORAL medical s.r.o.62Not found in the FDA registerNot found in the Canadian register
PROMA REHA, s.r.o.59Not found in the FDA registerNot found in the Canadian register
Bioline Products s.r.o.54Not found in the FDA registerNot found in the Canadian register
ALP ecology s.r.o.52Registered with FDANot found in the Canadian register
MEDIPLAST CZ, s.r.o.43Not found in the FDA registerNot found in the Canadian register
MEDKONSULT medical technology s.r.o.42Registered with FDANot found in the Canadian register
VAKUFORM s.r.o.39Not found in the FDA registerNot found in the Canadian register
MARO - Mader, s.r.o.38Not found in the FDA registerNot found in the Canadian register
Ing. Petr Švec - PENTA s.r.o.37Not found in the FDA registerNot found in the Canadian register
SpofaDental a.s.37Registered with FDANot found in the Canadian register
BISMED, s.r.o.35Not found in the FDA registerNot found in the Canadian register
Viacell s.r.o.35Not found in the FDA registerNot found in the Canadian register
Karel Hrnčíř - BIOMAG34Not found in the FDA registerNot found in the Canadian register
VINAMET CZ s.r.o.34Not found in the FDA registerNot found in the Canadian register
RAMED Kopřivnice s.r.o.33Not found in the FDA registerNot found in the Canadian register
AVEFLOR, a.s.32Not found in the FDA registerNot found in the Canadian register
Handicap trade s.r.o.32Not found in the FDA registerNot found in the Canadian register
EGO Zlín, spol. s r.o.28Not found in the FDA registerNot found in the Canadian register
ALFAMEDIC s.r.o.26Not found in the FDA registerNot found in the Canadian register
LB BOHEMIA, s.r.o.26Not found in the FDA registerNot found in the Canadian register
Mego Pro s.r.o.25Not found in the FDA registerNot found in the Canadian register
Flídr medical s.r.o.24Not found in the FDA registerNot found in the Canadian register
SKALAB s.r.o.24Not found in the FDA registerNot found in the Canadian register
MOLITAN a.s.23Not found in the FDA registerNot found in the Canadian register
Zdravotní ústav se sídlem v Ostravě22Not found in the FDA registerNot found in the Canadian register
GENERI BIOTECH s.r.o.21Not found in the FDA registerNot found in the Canadian register
PURTEX s.r.o.20Registered with FDANot found in the Canadian register
ROYAX, s.r.o.20Not found in the FDA registerNot found in the Canadian register
BMT Medical Technology s.r.o.18Not found in the FDA registerLicensed in Canada
HARTMANN - RICO a.s.18Not found in the FDA registerNot found in the Canadian register
Lukáš Balihar16Not found in the FDA registerNot found in the Canadian register
EKOVUK MEDI, s.r.o.15Not found in the FDA registerNot found in the Canadian register
NewWaterMeaning s.r.o.15Not found in the FDA registerNot found in the Canadian register
Drylock Technologies s.r.o.14Registered with FDANot found in the Canadian register
Medirekt partner s.r.o.14Not found in the FDA registerNot found in the Canadian register
Solift, s.r.o.13Not found in the FDA registerNot found in the Canadian register
MEDICEM Technology s.r.o.12Registered with FDALicensed in Canada
MEDIROL s.r.o.12Not found in the FDA registerNot found in the Canadian register
Svárovský, s.r.o.12Not found in the FDA registerNot found in the Canadian register
HANDICAP, a.s.11Not found in the FDA registerNot found in the Canadian register
SITIN LAB s.r.o.11Not found in the FDA registerNot found in the Canadian register
MEDICA FILTER spol. s r.o.10Not found in the FDA registerNot found in the Canadian register
Contipro a.s.9Not found in the FDA registerNot found in the Canadian register
Cosmonde, a.s.9Not found in the FDA registerNot found in the Canadian register
BTC Pharma s.r.o.8Not found in the FDA registerNot found in the Canadian register
ORTOSERVIS s.r.o.8Not found in the FDA registerNot found in the Canadian register
VH Pharma a.s.8Not found in the FDA registerNot found in the Canadian register
VINCENTKA a.s.8Not found in the FDA registerNot found in the Canadian register
I.T.A.-Intertact s.r.o.7Not found in the FDA registerNot found in the Canadian register
ALPA, a.s.6Not found in the FDA registerNot found in the Canadian register
CHIS, s.r.o.6Not found in the FDA registerNot found in the Canadian register
DaTOM Česká republika, s.r.o.6Not found in the FDA registerNot found in the Canadian register
Parabel s.r.o.6Registered with FDANot found in the Canadian register
ŠTĚPAŘ s.r.o.6Not found in the FDA registerNot found in the Canadian register
FIDE s.r.o.5Not found in the FDA registerNot found in the Canadian register
Ultina s.r.o.5Not found in the FDA registerNot found in the Canadian register
VR LIFE s.r.o.5Not found in the FDA registerNot found in the Canadian register

Other countries