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

113 manufacturers registered in Denmark with at least 5 devices declared in the European database. Of these, 75 were not found in the U.S. FDA establishment register, 36 were matched, and 2 have a similar name that needs checking.

ManufacturerDevices FDA
Coloplast A/S11 480Registered with FDA
SBO Hearing A/S10 427Not found in the FDA register
WSAUD A/S8 641Not found in the FDA register
Widex A/S2 913Not found in the FDA register
Eto Garments ApS1 454Not found in the FDA register
Dansac A/S912Not found in the FDA register
Care Design I/S725Not found in the FDA register
Borch Textile Group A/S720Not found in the FDA register
GN Hearing A/S684Registered with FDA
Pressalit A/S603Similar name found — unverified
Etac A/S455Registered with FDA
Winncare Nordic362Registered with FDA
Natus Medical Denmark ApS358Registered with FDA
Ambu A/S353Registered with FDA
Etac Immedia A/S352Registered with FDA
Levitate Technology ApS324Registered with FDA
Mobilex A/S312Not found in the FDA register
Excellent Systems A/S283Not found in the FDA register
ZiboCare A/S271Not found in the FDA register
MvG Consult ApS259Not found in the FDA register
Protac A/S244Not found in the FDA register
Cobi Rehab A/S207Not found in the FDA register
DGS Diagnostics A/S176Not found in the FDA register
R82 A/S160Registered with FDA
BGI EUROPE A/S140Not found in the FDA register
Simonsen & Weel A/S139Not found in the FDA register
Schou Rasmussen ApS134Not found in the FDA register
Furine ApS124Registered with FDA
HMN A/S117Not found in the FDA register
Ropox a/s115Registered with FDA
Wolturnus A/S99Not found in the FDA register
Levabo ApS97Not found in the FDA register
CODAN Medical ApS86Registered with FDA
Con-Lens ApS84Not found in the FDA register
SSI Diagnostica A/S84Registered with FDA
Vermund Larsen A/S68Not found in the FDA register
CMS Dental64Similar name found — unverified
Qufora A/S53Not found in the FDA register
Vikta ApS51Not found in the FDA register
Jb-Medico ApS47Not found in the FDA register
Par Scientific Denmark ApS46Not found in the FDA register
DANISH HEALTHCARE ApS45Not found in the FDA register
QA MED Solutions45Not found in the FDA register
Abena A/S41Not found in the FDA register
DNTL Nordic ApS41Not found in the FDA register
PF mobility ApS40Not found in the FDA register
by ACRE Aps36Registered with FDA
Select Sport A/S35Not found in the FDA register
Cortex Technology Aps34Registered with FDA
Eldon Biologicals A/S34Registered with FDA
Knop Elektronik A/S33Not found in the FDA register
PentaBase A/S33Not found in the FDA register
Spilerdug ApS33Not found in the FDA register
RefLab Aps31Not found in the FDA register
Medema A/S30Not found in the FDA register
ExamVision A/S29Registered with FDA
Novo Nordisk A/S29Registered with FDA
Vivostat A/S28Not found in the FDA register
BiopSafe ApS26Not found in the FDA register
Cercare Medical A/S26Registered with FDA
Danrehab A/S25Not found in the FDA register
NRT-Nordisk Røntgen Teknik A/S24Not found in the FDA register
Opitek International24Not found in the FDA register
Sahva A/S24Not found in the FDA register
Vitrolife A/S24Registered with FDA
Prosenso ApS23Not found in the FDA register
GP Medical Devices A/S21Registered with FDA
Plum Safety ApS20Registered with FDA
Canon Medical Informatics A/S19Registered with FDA
JØRN IVERSEN RØDEKRO ApS19Not found in the FDA register
Careturner A/S17Not found in the FDA register
MelaMedic ApS17Not found in the FDA register
Zantey ApS17Not found in the FDA register
NUNC A/S15Registered with FDA
CANNORDIC A/S14Not found in the FDA register
Unigroup ApS14Not found in the FDA register
2cureX A/S13Not found in the FDA register
Nordic-NeuroSTIM13Not found in the FDA register
SmokeQuit ApS12Not found in the FDA register
3Shape TRIOS A/S11Registered with FDA
Radiobotics ApS11Not found in the FDA register
TOOsonix A/S11Not found in the FDA register
BrainCapture ApS10Not found in the FDA register
Nordic Sense A/S10Not found in the FDA register
Unomedical A/S10Registered with FDA
AAG Aalborg Gummivarefabrik A/S9Not found in the FDA register
Auditdata A/S9Registered with FDA
BK Medical ApS9Registered with FDA
Innoventa Medica ApS9Registered with FDA
Oscilla A/S9Registered with FDA
Remecure ApS9Not found in the FDA register
3Shape A/S8Registered with FDA
BY CONNIEHANSEN 2015 ApS8Not found in the FDA register
Green Drain Europe ApS8Not found in the FDA register
H. Dam Kærgaard A/S8Not found in the FDA register
Henrotek A/S8Registered with FDA
IVFtech ApS8Not found in the FDA register
A/S Aabentoft7Not found in the FDA register
Microwarm ApS7Not found in the FDA register
Cortrium ApS6Not found in the FDA register
DDD-Diagnostic A/S6Not found in the FDA register
ExSeed Health ApS6Not found in the FDA register
Ferrosan Medical Devices A/S6Registered with FDA
Goloo A/S6Not found in the FDA register
TA. Service A/S6Not found in the FDA register
Axlab A/S5Not found in the FDA register
Blue Ocean Robotics ApS5Not found in the FDA register
Cardia International A/S5Not found in the FDA register
CathVision ApS5Registered with FDA
ErgoDenta ApS5Registered with FDA
Kellpo A/S5Not found in the FDA register
Monoqool5Registered with FDA
XO CARE A/S5Not found in the FDA register

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