EU → North America Device Access

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

106 manufacturers registered in Belgium with at least 5 devices declared in the European database. Of these, 72 were not found in the U.S. FDA establishment register, 26 were matched, and 8 have a similar name that needs checking.

Against the Canadian register, 87 of them were not found, 15 hold a Health Canada licence, and 4 need checking.

ManufacturerDevices FDAHealth Canada
HASA OPTIX2 581Registered with FDANot found in the Canadian register
Surgical Instruments Belgium1 289Registered with FDANot found in the Canadian register
Ontex BV1 075Registered with FDANot found in the Canadian register
GC Europe NV1 026Similar name found — unverifiedNot found in the Canadian register
Diagam S.A.959Registered with FDANot found in the Canadian register
LABORATORIA BOTA NV694Not found in the FDA registerNot found in the Canadian register
Ansell Healthcare Europe NV546Not found in the FDA registerNot found in the Canadian register
Euromi Biosciences514Not found in the FDA registerNot found in the Canadian register
Mondomed NV409Not found in the FDA registerNot found in the Canadian register
Barco NV350Registered with FDALicensed in Canada
EUROMI337Not found in the FDA registerNot found in the Canadian register
Alsico N.V.297Not found in the FDA registerNot found in the Canadian register
Orthobroker273Not found in the FDA registerNot found in the Canadian register
Handi-Move NV244Registered with FDANot found in the Canadian register
TERUMO EUROPE N.V.243Registered with FDALicensed in Canada
Surgi-Tec NV242Similar name found — unverifiedNot found in the Canadian register
MVS In Motion238Not found in the FDA registerNot found in the Canadian register
D-tek s.a.237Not found in the FDA registerNot found in the Canadian register
Vermeiren Group222Not found in the FDA registerNot found in the Canadian register
Hubert De Backer nv211Similar name found — unverifiedNot found in the Canadian register
Alan & Co157Not found in the FDA registerNot found in the Canadian register
RENOL150Not found in the FDA registerNot found in the Canadian register
Cypress Diagnostics139Not found in the FDA registerNot found in the Canadian register
Agfa NV135Not found in the FDA registerNot found in the Canadian register
Moovartes BV130Not found in the FDA registerNot found in the Canadian register
G-FLEX FLEXIBLE INSTRUMENTS EUROPE119Not found in the FDA registerNot found in the Canadian register
Materialise NV112Similar name found — unverifiedSimilar name found — unverified
mo-vis bv108Registered with FDANot found in the Canadian register
Oystershell NV86Similar name found — unverifiedLicensed in Canada
Johnson & Johnson International83Not found in the FDA registerLicensed in Canada
Plastiflex Group NV78Not found in the FDA registerNot found in the Canadian register
LaCAR MDx Technologies64Registered with FDANot found in the Canadian register
FertiPro61Similar name found — unverifiedSimilar name found — unverified
BEDAL INTERNATIONAL58Registered with FDANot found in the Canadian register
2ingis55Not found in the FDA registerNot found in the Canadian register
BELGIAN DIAGNOSTIC COMPANY52Not found in the FDA registerNot found in the Canadian register
Jack & Troy BV52Not found in the FDA registerNot found in the Canadian register
M.Ex.T. Belgium52Not found in the FDA registerNot found in the Canadian register
Haelvoet NV51Not found in the FDA registerNot found in the Canadian register
OneLife SA51Not found in the FDA registerNot found in the Canadian register
Tokai Optecs NV49Not found in the FDA registerNot found in the Canadian register
VWR International bv49Not found in the FDA registerLicensed in Canada
Orthophysics43Not found in the FDA registerNot found in the Canadian register
Naqi NV41Not found in the FDA registerNot found in the Canadian register
PRIME Medical Solutions36Not found in the FDA registerNot found in the Canadian register
YVSOLAB NV35Not found in the FDA registerNot found in the Canadian register
Motron NV33Not found in the FDA registerNot found in the Canadian register
Zentech s.a.33Not found in the FDA registerNot found in the Canadian register
Orfit Industries31Registered with FDANot found in the Canadian register
Bioncise NV27Registered with FDALicensed in Canada
Entusia BV27Not found in the FDA registerNot found in the Canadian register
KOBA Vision27Not found in the FDA registerNot found in the Canadian register
Laboratoire Huckert's International25Not found in the FDA registerNot found in the Canadian register
Ergotrics24Not found in the FDA registerNot found in the Canadian register
TITAMED24Registered with FDANot found in the Canadian register
Lifestream Pharma N.V.23Registered with FDANot found in the Canadian register
MOBILE-TECHNICS BV21Not found in the FDA registerNot found in the Canadian register
Devroye Instruments SRL20Registered with FDANot found in the Canadian register
Lys Medical20Not found in the FDA registerNot found in the Canadian register
tacco international nv20Not found in the FDA registerNot found in the Canadian register
Belintra NV19Not found in the FDA registerNot found in the Canadian register
H&O Equipments nv/sa19Not found in the FDA registerNot found in the Canadian register
SPRONKEN ORTHOPEDIE19Not found in the FDA registerNot found in the Canadian register
F Care Systems18Registered with FDALicensed in Canada
Medisoft S.A.18Registered with FDALicensed in Canada
MedXPress.Pro16Registered with FDANot found in the Canadian register
Reskin Medical NV16Not found in the FDA registerNot found in the Canadian register
CoMoveIT15Not found in the FDA registerNot found in the Canadian register
LIEVENS-LANCKMAN BV14Not found in the FDA registerNot found in the Canadian register
Miracor Medical SA14Not found in the FDA registerNot found in the Canadian register
Air Liquide Medical sa12Not found in the FDA registerSimilar name found — unverified
Alphadent NV12Not found in the FDA registerNot found in the Canadian register
Axiles Bionics BV12Not found in the FDA registerNot found in the Canadian register
GymnaUniphy N.V.12Not found in the FDA registerLicensed in Canada
Immunodiagnostic Systems SA12Registered with FDALicensed in Canada
Batojan11Not found in the FDA registerNot found in the Canadian register
Materni11Not found in the FDA registerNot found in the Canadian register
Advanced Practical Diagnostics10Similar name found — unverifiedSimilar name found — unverified
Minze NV10Registered with FDANot found in the Canadian register
Roam Technology NV10Not found in the FDA registerNot found in the Canadian register
Acar'Up9Not found in the FDA registerNot found in the Canadian register
Laboratoires Marie-Louise SRL9Not found in the FDA registerNot found in the Canadian register
icometrix8Registered with FDALicensed in Canada
MedEnvision bv8Not found in the FDA registerNot found in the Canadian register
Medical Data Technology8Not found in the FDA registerNot found in the Canadian register
Nomics8Not found in the FDA registerNot found in the Canadian register
Biocartis NV7Registered with FDALicensed in Canada
Byteflies NV7Not found in the FDA registerNot found in the Canadian register
LABORATOIRE PURESSENTIEL7Not found in the FDA registerNot found in the Canadian register
NorrDia Belgium bv7Not found in the FDA registerNot found in the Canadian register
Omega Pharma International NV7Not found in the FDA registerNot found in the Canadian register
Sylphar nv7Not found in the FDA registerNot found in the Canadian register
Tosoh Europe N.V.7Not found in the FDA registerNot found in the Canadian register
4power4-PowerStand6Not found in the FDA registerNot found in the Canadian register
CEFALY Technology6Registered with FDALicensed in Canada
Coris BioConcept6Not found in the FDA registerLicensed in Canada
Idevax BV6Not found in the FDA registerNot found in the Canadian register
Jabbla6Registered with FDANot found in the Canadian register
MoveUp6Registered with FDANot found in the Canadian register
P³Lab6Not found in the FDA registerNot found in the Canadian register
SERB SA6Not found in the FDA registerLicensed in Canada
Sterima6Not found in the FDA registerNot found in the Canadian register
Axinesis5Not found in the FDA registerNot found in the Canadian register
Fico bv5Not found in the FDA registerNot found in the Canadian register
Materialise Motion5Similar name found — unverifiedNot found in the Canadian register
Sunrise SA5Registered with FDANot found in the Canadian register

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