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Data / Medical devices / Netherlands

Medical device makers in the Netherlands: 174 FDA-registered establishments

174 establishments in the Netherlands are registered with the FDA to make medical devices for the US market, listing 395 device types. 88 have a 510(k) clearance or PMA approval on file and 16 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

  • NetherlandsCountry

Device types made here

Device types with the most registered makers in this country.

DeviceProduct codeMakers
System, Image Processing, RadiologicalLLZ10
Automated Radiological Image Processing SoftwareQIH8
Warmer, Thermal, Infusion FluidLGZ6
System, Measurement, Blood-Pressure, Non-InvasiveDXN6
Unit, Cryosurgical, AccessoriesGEH5
OximeterDQA5
System, Thermal RegulatingDWJ4
Computer, Diagnostic, ProgrammableDQK4
Orthosis, Limb BraceIQI4
Frame, SpectacleHQZ4
System, X-Ray, Tomography, ComputedJAK4
System, Planning, Radiation Therapy TreatmentMUJ4
Radiation Therapy Marking DeviceQRN4
System, X-Ray, AngiographicIZI3
Instrument, Manual, Surgical, General UseMDM3
Intervertebral Fusion Device With Bone Graft, LumbarMAX3
Intervertebral Fusion Device With Bone Graft, CervicalODP3
Filler, Bone Void, Calcium CompoundMQV3
Neurological Stereotaxic InstrumentHAW3
Marker, Radiographic, ImplantableNEU3
Transducer, Ultrasonic, DiagnosticITX3
System, Imaging, Pulsed Echo, UltrasonicIYO3
Stand, InfusionFOX3
Tray, Surgical, InstrumentFSM3
Lamp, Infrared, Therapeutic HeatingILY3
Continuous Measurement ThermometerFLL3
Plethysmograph, ImpedanceDSB3
System, Nuclear Magnetic Resonance ImagingLNH3
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI3
Powered Stairway Chair LiftPCD3
Exerciser, PoweredBXB3
Topographer, Corneal, Ac-PoweredMMQ3
Temporary Tissue MarkerPBY3
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software DeviceQHA3
Fastener, Fixation, Nondegradable, Soft TissueMBI2
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE2
Orthopedic Manual Surgical InstrumentLXH2
ReamerHTO2
Rod, Fixation, Intramedullary And AccessoriesHSB2
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2
Growing Rod SystemPGM2
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2
Multi-Analyte Controls, All Kinds (Assayed)JJY2
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG2
Wire, Guide, CatheterDQX2
Catheter, Intravascular, DiagnosticDQO2
Catheter, PercutaneousDQY2
System, Applicator, Radionuclide, Remote-ControlledJAQ2
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY2
RetractorGAD2
Cuff, NerveJXI2
Knife, OphthalmicHNN2
Set, I.V. Fluid TransferLHI2
System, Imaging, Pulsed Doppler, UltrasonicIYN2
Garment, Protective, For IncontinenceEYQ2
ProbeHXB2
Forceps, OphthalmicHNR2
Scissors, OphthalmicHNF2
Spatula, OphthalmicHND2
Depressor, OrbitalHNX2
Cannula, OphthalmicHMX2
Transducer, UltrasonicJOP2
Orthosis, LumbarIQE2
Joint, Knee, External BraceITQ2
Disinfectant, Medical DevicesLRJ2
Light Based Over The Counter Wrinkle ReductionOHS2
Over-The-Counter Powered Light Based Laser For AcneOLP2
Light Based Over-The-Counter Hair RemovalOHT2
Hand, External Limb Component, MechanicalIRA2
Sunglasses (Non-Prescription Including Photosensitive)HQY2
HemocytometerGHO2
Container, Specimen Mailer And Storage, Non-SterileNNK2
Transducer, Pressure, Catheter TipDXO2
Stimulator, Electrical, Evoked ResponseGWF2
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2
Interventional Fluoroscopic X-Ray SystemOWB2
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2
Table, RadiologicKXJ2
Cassettes, TissueIDZ2
Catheter, Ultrasound, IntravascularOBJ2
Laser, OphthalmicHQF2
System, Network And Communication, Physiological MonitorsMSX2
Amplifier And Signal Conditioner, Transducer SignalDRQ2
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2
Accessories, WheelchairKNO2
Plate, Base, ShellacEEA2
Lift, Patient, Non-Ac-PoweredFSA2
Accelerator, Linear, MedicalIYE2
System, Perfusion, KidneyKDN2
System, Nuclear Magnetic Resonance SpectroscopicLNI2
Additively Manufactured, Preformed, Resin Denture ToothPZY2
EndoilluminatorMPA2
Instrument, Quality-Assurance, RadiologicLHO2
Collimator, Automatic, RadiographicIZW2
Treadmill, PoweredIOL2
Joint, Knee, External Limb ComponentISY2
Collimator, Manual, RadiographicIZX2
Ultraviolet Radiation Disinfection Chamber DeviceSCS2
Pin, Fixation, SmoothHTY1
Fastener, Fixation, Biodegradable, Soft TissueMAI1

Makers in the Netherlands

Best documented first: most 510(k) clearances and PMA approvals.

MakerLocationDevice types510(k) clearancesPMA approvalsRecall eventsSource
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, Netherlands713000api.fda.gov
BRDHRoden Drenthe, Netherlands357110api.fda.gov
Applied Medical EuropeAmersfoort Utrecht, Netherlands245400api.fda.gov
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, Netherlands1250011api.fda.gov
Nucletron B.V.VEENENDAAL Utrecht, Netherlands53202api.fda.gov
Philips Medical Systems Nederland B.V.Best Noord-Brabant, Netherlands42301api.fda.gov
Sevenground Trading B.V.Dordrecht Zuid-Holland, Netherlands62100api.fda.gov
Masena Invest, BVDordrecht Zuid-Holland, Netherlands71700api.fda.gov
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, Netherlands3617054api.fda.gov
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.ZUIDLAND Zuid-Holland, Netherlands241302api.fda.gov
Cavex Holland B.V.HAARLEM Noord-Holland, Netherlands141200api.fda.gov
Philips Medical Systems Nederland B.V.Eindhoven Noord-Brabant, Netherlands81205api.fda.gov
Silk'n Beauty Ltd.Rotterdam Zuid-Holland, Netherlands131200api.fda.gov
Technomed EuropeKerkrade Limburg, Netherlands61203api.fda.gov
Eurotrol B.V.EDE Gelderland, Netherlands81100api.fda.gov
Hollister Services BVRoosendaal Noord-Brabant, Netherlands61100api.fda.gov
Kuros Biosciences BVBilthoven Utrecht, Netherlands11100api.fda.gov
Pie Medical Imaging B.V.MAASTRICHT Limburg, Netherlands41002api.fda.gov
Menicon B.V.Emmen Drenthe, Netherlands3810api.fda.gov
Vertex-Dental B.V.Soesterberg Utrecht, Netherlands12900api.fda.gov
Screenpoint MedicalNijmegen Gelderland, Netherlands3800api.fda.gov
Enraf-Nonius B.V.ROTTERDAM Zuid-Holland, Netherlands12700api.fda.gov
IMDS Operations B.V.Roden Groningen, Netherlands2700api.fda.gov
Light Tree Ventures Europe B.V.'S-Gravenhage Zuid-Holland, Netherlands4700api.fda.gov
Philips Consumer Lifestyle B.V.Drachten Fryslan, Netherlands6700api.fda.gov
Baat Medical Products B.V.Hengelo Overijssel, Netherlands10600api.fda.gov
Boston Scientific International BV, European Dist. Ctr.KERKRADE Limburg, Netherlands9240api.fda.gov
Amo Groningen BVGroningen, Netherlands6320api.fda.gov
Macromedics BVMoordrecht Zuid-Holland, Netherlands2500api.fda.gov
Philips Medical Systems Nederland B.V.Best Noord-Brabant, Netherlands1500api.fda.gov
Rovers Medical Devices B.V.OSS Noord-Brabant, Netherlands3500api.fda.gov
TSC LifeAlmelo Overijssel, Netherlands3500api.fda.gov
The Surgical Company International B.V.Amsterdam Noord-Holland, Netherlands3500api.fda.gov
Medis Medical Imaging Systems, B.V.LEIDEN Zuid-Holland, Netherlands3400api.fda.gov
Onera B.V.Eindhoven Noord-Brabant, Netherlands3400api.fda.gov
Polyganics Holding BVGroningen, Netherlands4400api.fda.gov
BD Kiestra B.V.Drachten Fryslan, Netherlands9301api.fda.gov
Cablon Medical B.V.LEUSDEN Utrecht, Netherlands3300api.fda.gov
Cardiotek BVGL SIttard Limburg, Netherlands1302api.fda.gov
CD LeycomHengelo Overijssel, Netherlands5300api.fda.gov
Edwards Lifesciences Holding B.V.AMSTERDAM Noord-Holland, Netherlands3300api.fda.gov
Koninklijke (royal) Utermohlen N.V.Wolvega Fryslan, Netherlands1300api.fda.gov
Lode B.V.Groningen, Netherlands4300api.fda.gov
NICo-Lab B.V.Amsterdam Noord-Holland, Netherlands2300api.fda.gov
Ophtec BVGroningen, Netherlands4120api.fda.gov
Pendracare International B.V.Leek Groningen, Netherlands1300api.fda.gov
UltrasunHENGELO Overijssel, Netherlands4300api.fda.gov
Agendia NVAmsterdam Noord-Holland, Netherlands2200api.fda.gov
Fysicon BVOss Noord-Brabant, Netherlands3200api.fda.gov
Med Pro Medical B.VVeenendaal Utrecht, Netherlands6200api.fda.gov
Microtek Medical B.V.Zutphen Gelderland, Netherlands5200api.fda.gov
ONWARD Medical N.V.Eindhoven Noord-Brabant, Netherlands1200api.fda.gov
Philips Medical Systems Nederland B.V.Best Noord-Brabant, Netherlands2200api.fda.gov
QlradAlmere Flevoland, Netherlands3200api.fda.gov
Theo Manufacturing BVMaastricht Limburg, Netherlands1200api.fda.gov
Theotclab Healthcare B.V.Amsterdam Noord-Holland, Netherlands1200api.fda.gov
Thirona BVNijmegen Gelderland, Netherlands1200api.fda.gov
Vitreq BVVierpolders Zuid-Holland, Netherlands11201api.fda.gov
Amber Implants BVThe Hague Zuid-Holland, Netherlands1100api.fda.gov
AugmeditNaarden Noord-Holland, Netherlands2100api.fda.gov
Brain Science Tools BVDe Bilt Utrecht, Netherlands4100api.fda.gov
Bayer Medical Care B.V.Maastricht Limburg, Netherlands1100api.fda.gov
Corsano Health B.V.The Hague Zuid-Holland, Netherlands8100api.fda.gov
Comecer Netherlands b.v.Joure Fryslan, Netherlands1100api.fda.gov
Finapres Medical Systems B.V.Enschede Overijssel, Netherlands4101api.fda.gov
Frame Holland BVBurgerveen Noord-Holland, Netherlands2100api.fda.gov
GATT Technologies BVNijmegen Gelderland, Netherlands1010api.fda.gov
Huka B.V.Oldenzaal Overijssel, Netherlands1100api.fda.gov
Iq Products B.V.Groningen, Netherlands2100api.fda.gov
Lapsi HealthAmsterdam Noord-Holland, Netherlands1100api.fda.gov
LivassuredLeiden Zuid-Holland, Netherlands1100api.fda.gov
Mauser Benelux B.V.Oosterhout Noord-Brabant, Netherlands1100api.fda.gov
Medical Precision BVZwolle Overijssel, Netherlands1100api.fda.gov
Medicalvr BVNieuw-Vennep Noord-Holland, Netherlands1100api.fda.gov
Meditop BVMontfoort Utrecht, Netherlands2100api.fda.gov
Mriguidance B.V.Utrecht, Netherlands1100api.fda.gov
Medtronic Bakken Research Center B.V. (BRC)Maastricht Limburg, Netherlands2010api.fda.gov
Nordic Pharma BVGSiriusdreef, Netherlands1010api.fda.gov
Oldelft B.V.Delft Zuid-Holland, Netherlands4100api.fda.gov
Pronova Laboratories BVMuiden Noord-Holland, Netherlands2100api.fda.gov
Proton B.V.GM Sittard Limburg, Netherlands4100api.fda.gov
QFR Solutions BVLeiden Zuid-Holland, Netherlands2100api.fda.gov
Rollz International BVDelft Zuid-Holland, Netherlands3100api.fda.gov
Sirius Medical Systems B.V.Eindhoven Noord-Brabant, Netherlands2100api.fda.gov
U-Needle B.V.Enschede Overijssel, Netherlands1100api.fda.gov
Uv Smart Technologies B.V.Rijswijk Zuid-Holland, Netherlands2100api.fda.gov
VitalScientific B.V.SPANKEREN Gelderland, Netherlands9102api.fda.gov
Xvivo BVGroningen, Netherlands1100api.fda.gov
Ace And Tate E-Com BVAmsterdam Noord-Holland, Netherlands4000api.fda.gov
Adler Diamant BVCuijk Noord-Brabant, Netherlands1000api.fda.gov
Aim B.V.Brunssum Limburg, Netherlands3000api.fda.gov
Airmax B.V.Oegstgeest Zuid-Holland, Netherlands1000api.fda.gov
AmbroiseENSCHEDE Overijssel, Netherlands2000api.fda.gov
Aliform B.V.Maastricht Limburg, Netherlands1000api.fda.gov
Arion Holding B.V.Heerlen Limburg, Netherlands3000api.fda.gov
Attain Technologies BVHeerhugowaard Noord-Holland, Netherlands1000api.fda.gov
Basko Healthcare B.V.ZAANDAM Noord-Holland, Netherlands9000api.fda.gov
Batenburg Applied TechnologiesRotterdam Zuid-Holland, Netherlands2000api.fda.gov
Birr Biosciences BVBreukelen Utrecht, Netherlands2000api.fda.gov
Bloomdale EyewearRosmalen Noord-Brabant, Netherlands1000api.fda.gov
Blue Medical BVZaandam Noord-Holland, Netherlands1000api.fda.gov
Braedius Medical B.V.Huizen Noord-Holland, Netherlands1000api.fda.gov
Bridea Medical BVAmsterdam Noord-Holland, Netherlands1000api.fda.gov
Benchmark AlmeloAlmelo Overijssel, Netherlands1000api.fda.gov
Cam BioceramicsLEIDEN Zuid-Holland, Netherlands2000api.fda.gov
Cassini Technologies B.V.The Hague Zuid-Holland, Netherlands2000api.fda.gov
Curium Netherlands B.V.Petten Noord-Holland, Netherlands1000api.fda.gov
Demcon Bond3dEnschede Overijssel, Netherlands2000api.fda.gov
Demcon Production B.V.Enschede Overijssel, Netherlands11000api.fda.gov
Devi-Stairlifts BVOpmeer Noord-Holland, Netherlands1000api.fda.gov
Duphamed B.V.ALPHEN AAN DEN RIJN Zuid-Holland, Netherlands2000api.fda.gov
E.A.M Benelux B.VALMERE Flevoland, Netherlands1000api.fda.gov
Ecm Europe BVGemert Noord-Brabant, Netherlands1000api.fda.gov
Enta B.V.Bergen op Zoom Noord-Brabant, Netherlands1000api.fda.gov
European Medical Contract MFG.NIJMEGEN Gelderland, Netherlands2000api.fda.gov
Eaglet Eye Trading BVHouten Utrecht, Netherlands1000api.fda.gov
Essange ReagentsAmsterdam Noord-Holland, Netherlands2000api.fda.gov
Essity Operations Gennep B.V.GENNEP Limburg, Netherlands3000api.fda.gov
Essity Operations Hoogezand B.V.HOOGEZAND Groningen, Netherlands1000api.fda.gov
FA-Tech Diagnostics Europe BVDuiven Gelderland, Netherlands1000api.fda.gov
Fmi Medisch BVSchiedam Zuid-Holland, Netherlands39000api.fda.gov
HCM MedicalNijmegen Gelderland, Netherlands2000api.fda.gov
Hittech Multin BVDen Haag Zuid-Holland, Netherlands1000api.fda.gov
Humeca BVBorne Overijssel, Netherlands6000api.fda.gov
I-Med TechnologyMaastricht Limburg, Netherlands2000api.fda.gov
Ihb OperationsZwolle Overijssel, Netherlands1002api.fda.gov
Indes Healthcare B.V.Enschede Overijssel, Netherlands1000api.fda.gov
Jeta Molecular B.V.Utrecht, Netherlands1000api.fda.gov
Leja Products B.V.NIEUW VENNEP Noord-Holland, Netherlands1000api.fda.gov
Lopital Nederland B.V.Oisterwijk Noord-Brabant, Netherlands2000api.fda.gov
Mcroberts BVthe hague Zuid-Holland, Netherlands1000api.fda.gov
MeprotechHeerhugowaard Noord-Holland, Netherlands1000api.fda.gov
Mind MediaROERMOND-HERTEN Limburg, Netherlands1000api.fda.gov
Motek Medical B.V.Houten Noord-Brabant, Netherlands3001api.fda.gov
Move Engineering BVEDE GLD Gelderland, Netherlands2000api.fda.gov
Microtek Medical B.V. VarsseveldVARSSEVELD Gelderland, Netherlands2000api.fda.gov
Nea International BVMAASTRICHT-AIRPORT Limburg, Netherlands5000api.fda.gov
NTOC medische techniek B.VOss Noord-Brabant, Netherlands4000api.fda.gov
OTE PHARMA SOL bvUDEN Noord-Brabant, Netherlands1000api.fda.gov
OTN Implants B.V.Nijmegen Gelderland, Netherlands4000api.fda.gov
OtoliftBergambacht Zuid-Holland, Netherlands1000api.fda.gov
Patient Lifting Solutions BVVeenendaal Utrecht, Netherlands1000api.fda.gov
Pharmaspray B.V.VEENDAM Groningen, Netherlands2000api.fda.gov
Promolding BVDen Haag Zuid-Holland, Netherlands1000api.fda.gov
Prostem Hair B.V.Maastricht Limburg, Netherlands1000api.fda.gov
Philips Consumer Lifestyle B.V.Drachten Fryslan, Netherlands1000api.fda.gov
Prince Technologies B.V.Emmen Drenthe, Netherlands1000api.fda.gov
Rademaker Medical Instrumentss-Hertogenbosch Noord-Brabant, Netherlands1000api.fda.gov
Reboocon Bionics B.V.Pijnacker Zuid-Holland, Netherlands1000api.fda.gov
Relitech B.V.Nijkerk Gelderland, Netherlands1000api.fda.gov
Rodger B.V.Ravenstein Noord-Brabant, Netherlands1000api.fda.gov
Roger Eye DesignEtten-Leur Noord-Brabant, Netherlands1000api.fda.gov
RR MECHATRONICS Manufacturing B.V.ZWAAG Noord-Holland, Netherlands4000api.fda.gov
Rushwood B.V.Raamsdonksveer Noord-Brabant, Netherlands1000api.fda.gov
S.P.F. Plastics B.V.Zaltbommel Gelderland, Netherlands1000api.fda.gov
Sakura Finetek Europe B.V.Alphen aan den Rijn Zuid-Holland, Netherlands2000api.fda.gov
Savaria Nederland BVHeerhugowaard Noord-Holland, Netherlands1000api.fda.gov
Sonoco Plastics B.V.Berkel en Rodenrijs Zuid-Holland, Netherlands2000api.fda.gov
Soteria Medical B.V.Arnhem Gelderland, Netherlands1000api.fda.gov
Spark Holland BV.EMMEN Drenthe, Netherlands2000api.fda.gov
Spierings Orthopaedics B.V.NIJMEGEN Gelderland, Netherlands3000api.fda.gov
Stil B.V.Delft Zuid-Holland, Netherlands1000api.fda.gov
Synergie Nederland BVRaamsdonksveer Noord-Brabant, Netherlands1000api.fda.gov
Super Seton B.V.Amsterdam Noord-Holland, Netherlands1000api.fda.gov
United Care Products BVGroningen, Netherlands2000api.fda.gov
Unitron Group BVIJzendijke Zeeland, Netherlands9000api.fda.gov
Valuepack B.V.Nijmegen Gelderland, Netherlands2000api.fda.gov
Variass Medical Systems BVDrachten Fryslan, Netherlands1000api.fda.gov
VDL TBP ElectronicsDirksland Zuid-Holland, Netherlands2000api.fda.gov
Vicair B.V.WORMER Noord-Holland, Netherlands3000api.fda.gov
Varex Imaging Nederland B.V.Doetinchem Gelderland, Netherlands1002api.fda.gov
Wassenburg Medical B.V.Dodewaard Gelderland, Netherlands2000api.fda.gov
Youmedical B.V.Amsterdam Noord-Holland, Netherlands1000api.fda.gov
inMotion VR'S-Hertogenbosch Noord-Brabant, Netherlands1000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.