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Data / Medical devices / Singapore

Medical device makers in Singapore: 92 FDA-registered establishments

92 establishments in Singapore are registered with the FDA to make medical devices for the US market, listing 318 device types. 43 have a 510(k) clearance or PMA approval on file and 2 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.

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  • SingaporeCountry

Device types made here

Device types with the most registered makers in this country.

DeviceProduct codeMakers
System, Imaging, Pulsed Echo, UltrasonicIYO5
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG4
Set, Administration, IntravascularFPA4
Transducer, Ultrasonic, DiagnosticITX4
Lenses, Soft Contact, Daily WearLPL4
Reagents For Molecular Diagnostic Test SystemsPFT4
Ventilatory Effort RecorderMNR4
Syringe, PistonFMF3
Counter, Differential CellGKZ3
Instrumentation For Clinical Multiplex Test SystemsNSU3
Needle, Hypodermic, Single LumenFMI3
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ3
Catheter, Intravascular, DiagnosticDQO3
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA3
Stand, InfusionFOX3
System, Image Processing, RadiologicalLLZ3
Ventilator, Non-Continuous (Respirator)BZD3
Sunglasses (Non-Prescription Including Photosensitive)HQY3
Device, Positive Pressure Breathing, IntermittentNHJ3
High Throughput Dna Sequence AnalyzerPFF3
Laparoscope, General & Plastic SurgeryGCJ2
Medical Device Data SystemOUG2
Slide Stainer, AutomatedKPA2
Mass Spectrometer, Clinical UseDOP2
Catheter, PercutaneousDQY2
Ureteroscope And Accessories, Flexible/RigidFGB2
System, Imaging, Pulsed Doppler, UltrasonicIYN2
Lens, Contact, (Disposable)MVN2
Massager, Therapeutic, ElectricISA2
Handle, ScalpelGDZ2
Instrument, Cutting, OrthopedicHTZ2
Tubing, Pressure And AccessoriesBYX2
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2
Transducer, Blood-Pressure, ExtravascularDRS2
Catheter, Angioplasty, Peripheral, TransluminalLIT2
System, Measurement, Blood-Pressure, Non-InvasiveDXN2
Probe, ThermodilutionKRB2
Computer, Blood-PressureDSK2
Real Time Nucleic Acid Amplification SystemOOI2
Instrumentation, High Pressure Liquid ChromatographyLDM2
OximeterDQA2
Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX2
Implantable Pulse Generator, Pacemaker (Non-Crt)LWP2
Implantable Cardioverter Defibrillator (Non-Crt)LWS2
Pulse Generator, Permanent, ImplantableNVZ2
Implantable Pacemaker Pulse-GeneratorDXY2
Frame, SpectacleHQZ2
Permanent Pacemaker ElectrodeDTB2
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN2
Station, Pipetting And Diluting, For Clinical UseJQW2
Clinical Sample ConcentratorJJH2
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2
Detector And Alarm, ArrhythmiaDSI2
Burst Suppression Detection Software For ElectroencephalographORT2
Index-Generating Electroencephalograph SoftwareOLW2
Reduced- Montage Standard ElectroencephalographOMC2
System, Isokinetic Testing And EvaluationIKK2
Tomography, Optical CoherenceOBO2
Percussor, Powered-ElectricBYI2
Interactive Rehabilitation Exercise Device, Prescription UseQKC2
Electrosurgical, Cutting & Coagulation & AccessoriesGEI1
System, X-Ray, AngiographicIZI1
Orthopedic Manual Surgical InstrumentLXH1
Instrument, Manual, Surgical, General UseMDM1
Intervertebral Fusion Device With Bone Graft, LumbarMAX1
Stimulator, NerveETN1
Neurosurgical Nerve LocatorPDQ1
Methyl Methacrylate For CranioplastyGXP1
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD1
Light Source, Fiberoptic, RoutineFCW1
Calibrator, SecondaryJIT1
Glucose Oxidase, GlucoseCGA1
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1
Assay, Glycosylated HemoglobinLCP1
Immunoassay Method, Troponin SubunitMMI1
Test, Cystatin CNDY1
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1
Albumin, Fitc, Antigen, Antiserum, ControlDDZ1
Prealbumin, Antigen, Antiserum, ControlJZJ1
Immunohistochemistry Assay, Antibody, Progesterone ReceptorMXZ1
Igm, Fitc, Antigen, Antiserum, ControlDFS1
Immunohistochemistry Reagents And KitsNJT1
System, Test, Beta-2-Microglobulin ImmunologicalJZG1
Igg, Fitc, Antigen, Antiserum, ControlDGK1
Mounting MediaLEB1
Research Use Only/PathologyOTU1
Lambda, Fitc, Antigen, Antiserum, ControlDES1
Retinol-Binding Protein, Antigen, Antiserum, ControlCZS1
Complement C4, Antigen, Antiserum, ControlDBI1
Agent, ClearingKEM1
Coverslips, Microscope SlideKES1
Complement C3, Antigen, Antiserum, ControlCZW1
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality DetectionPFX1
Slides, MicroscopeKEW1
System, Test, Her-2/Neu, IhcMVC1
Stains, Dye SolutionLEE1
Products, Red-Cell Lysing ProductsGGK1

Makers in Singapore

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

MakerLocationDevice types510(k) clearancesPMA approvalsRecall eventsSource
HARPS Investment Asia Pte. Ltd.Singapore Central Singapore, Singapore63300api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.Singapore North East, Singapore452820api.fda.gov
Bioptimal International Pte. Ltd.SINGAPORE South East, Singapore81400api.fda.gov
Medtronic Singapore Operations Pte LtdSingapore Central Singapore, Singapore10740api.fda.gov
Merit Medical Singapore Pte. Ltd.SINGAPORE Central Singapore, Singapore121100api.fda.gov
Becton Dickinson Medical (singapore)SINGAPORE North West, Singapore51000api.fda.gov
CMT Health Pte. Ltd.Singapore, Singapore111000api.fda.gov
Hill-Rom Services Private LimitedSingapore North East, Singapore21000api.fda.gov
CIBA VISION ASIAN MANUFACTURING AND LOGISTICS Pte. Ltd.SINGAPORE South West, Singapore2900api.fda.gov
EDWARDS LIFESCIENCES (SINGAPORE) Pte LtdChangi South East, Singapore8080api.fda.gov
JMS Singapore Pte. LtdSINGAPORE Central Singapore, Singapore5700api.fda.gov
Biobot Surgical Pte. Ltd.Singapore South West, Singapore4600api.fda.gov
Clearlab SG Pte, Ltd.SINGAPORE South East, Singapore2500api.fda.gov
NSP Tech Pte LtdSingapore Central Singapore, Singapore4500api.fda.gov
Ulike International Industrial Pte. Ltd.Singapore North West, Singapore5500api.fda.gov
Amt Pte. Ltd.Singapore South West, Singapore1300api.fda.gov
Eko.ai Pte. Ltd.Singapore Central Singapore, Singapore2300api.fda.gov
Pasture Pharma Pte LtdCorporation Place Central Singapore, Singapore3300api.fda.gov
Sivantos Pte LtdSingapore South East, Singapore5300api.fda.gov
Venner Medical (singapore) Pte LtdSingapore Central Singapore, Singapore4300api.fda.gov
Aevice Health Pte. Ltd.Singapore North East, Singapore2200api.fda.gov
Healkee Medical Pte. Ltd.Singapore North West, Singapore2200api.fda.gov
Life Technologies Holdings Pte Ltd.SINGAPORE North West, Singapore8202api.fda.gov
Medipurpose Pte. Ltd.SINGAPORE Central Singapore, Singapore3200api.fda.gov
Renew Group Private LimitedSingapore Central Singapore, Singapore2200api.fda.gov
Respiree Pte LtdSingapore Central Singapore, Singapore1200api.fda.gov
ResMed Asia Pte. Ltd.Singapore South West, Singapore7200api.fda.gov
Venture Corporation LimitedSingapore North East, Singapore5200api.fda.gov
Vantive Manufacturing Pte. Ltd.SINGAPORE Central Singapore, Singapore4200api.fda.gov
Acme Monaco Asia Pte. Ltd.Singapore Central Singapore, Singapore1100api.fda.gov
Hoya Medical Singapore Pte LtdSingapore Central Singapore, Singapore1010api.fda.gov
Icm Pharma Pte LtdSingapore Central Singapore, Singapore2100api.fda.gov
Jabil Circuit (Singapore) Pte LtdSingapore Central Singapore, Singapore15100api.fda.gov
Leica Instruments (singapore) Pte Ltd.SINGAPORE South West, Singapore6100api.fda.gov
Lifetrack Medical Systems Private Ltd.Singapore Central Singapore, Singapore1100api.fda.gov
Menicon Singapore Pte. Ltd.Singapore South West, Singapore1100api.fda.gov
Menicon Singapore Pte. Ltd. (Site 2)SINGAPORE South West, Singapore1100api.fda.gov
Osteopore International Pte LtdSingapore South West, Singapore1101api.fda.gov
Pranaq Pte. Ltd.Singapore Central Singapore, Singapore1100api.fda.gov
Quantumtx Pte. Ltd.Singapore Central Singapore, Singapore2100api.fda.gov
SG Endoscopy Pte LtdSingapore North East, Singapore1100api.fda.gov
Sirtex Singapore Manufacturing Pte LtdSingapore Central Singapore, Singapore5010api.fda.gov
Vela Operations Singapore Pte LtdSingapore Central Singapore, Singapore8100api.fda.gov
AB SCIEX Pte. Ltd.Woodlands Central Industrial Estate Central Singapore, Singapore2000api.fda.gov
Articares Pte LtdSINGAPORE Central Singapore, Singapore1000api.fda.gov
Aurora Technology Pte. Ltd.Singapore North East, Singapore1000api.fda.gov
Bestway Singapore Resources Pte.ltd.Singapore, Singapore1000api.fda.gov
Beyonics International Pte. Ltd.SINGAPORE North West, Singapore3000api.fda.gov
Biotronik Apm Ii Pte. LtdSingapore South East, Singapore11000api.fda.gov
Biotronik Apm Pte. LtdSingapore South East, Singapore3000api.fda.gov
Bothwin Medical Technology (SG) Pte. Ltd.Singapore Central Singapore, Singapore26000api.fda.gov
Bio-Rad Laboratories (Singapore) Pte. Ltd.Singapore Central Singapore, Singapore9000api.fda.gov
Carecam Pte. Ltd.SINGAPORE Central Singapore, Singapore1000api.fda.gov
CEI Pte LtdSingapore Central Singapore, Singapore1000api.fda.gov
Celestica Electronics (S) Pte Ltd.Singapore Central Singapore, Singapore7000api.fda.gov
Cornerstone Manufacturing Pte. Ltd.Singapore, Singapore2000api.fda.gov
Dyson Operations Pte LtdSingapore Central Singapore, Singapore1000api.fda.gov
Emerald Medical Services Pte. LtdSingapore North West, Singapore5000api.fda.gov
Emsley Pte. Ltd.SINGAPORE South West, Singapore2000api.fda.gov
ESCO Micro Pte. LtdSingapore Central Singapore, Singapore1000api.fda.gov
Essilor Asia Pacific PTE LTDSingapore Central Singapore, Singapore2000api.fda.gov
Fong's Engineering & Manufacturing Private LimitedSingapore Central Singapore, Singapore13000api.fda.gov
Forefront Medical Technology (pte) Ltd.SINGAPORE South West, Singapore4000api.fda.gov
Futureview Textile Trading Pte. Ltd.SINGAPORE North East, Singapore1000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, Singapore32000api.fda.gov
Fong's Engineering & Manufacturing Private LimitedSingapore South East, Singapore2000api.fda.gov
GES Singapore Pte LtdSingapore North West, Singapore1000api.fda.gov
Golden Season Pte LtdSINGAPORE North West, Singapore12000api.fda.gov
Innobrace Orthodontics Pte LtdSINGAPORE Central Singapore, Singapore1000api.fda.gov
Illumina Singapore Pte. Ltd.Singapore Central Singapore, Singapore2000api.fda.gov
Integrated Lens TechnologySINGAPORE South East, Singapore1000api.fda.gov
Kinexcs Pte Ltd.Singapore, West Central Singapore, Singapore2000api.fda.gov
Life Technologies Holdings Pte LtdJurong West North West, Singapore2000api.fda.gov
Meiban Micro Pte LtdSingapore Central Singapore, Singapore4000api.fda.gov
Millennium Enterprise Pte LtdSINGAPORE Central Singapore, Singapore7000api.fda.gov
MP Biomedicals Asia Pacific Pte LtdSingapore Central Singapore, Singapore1000api.fda.gov
Neurowyzr Pte Ltd.Singapore Central Singapore, Singapore1000api.fda.gov
OSIM International Pte. Ltd.SINGAPORE South East, Singapore2000api.fda.gov
Quasar Medical (singapore) Pte. Ltd.Singapore North West, Singapore2000api.fda.gov
Racer Technology Pte LtdSINGAPORE South East, Singapore6000api.fda.gov
Robust Care International LimitedSINGAPORE Central Singapore, Singapore1000api.fda.gov
Roceso Technologies Pte. Ltd.Singapore, West South West, Singapore4000api.fda.gov
Revvity Singapore Pte LtdSingapore Central Singapore, Singapore1000api.fda.gov
Smicna Pte LtdSingapore Central Singapore, Singapore3000api.fda.gov
SP Manufacturing Pte LtdSingapore Central Singapore, Singapore1000api.fda.gov
Sunningdale Tech LtdSingapore South West, Singapore1000api.fda.gov
Synphne Pte LtdSingapore South East, Singapore1000api.fda.gov
Sys-Mac Automation Engineering Pte LtdSingapore North West, Singapore3000api.fda.gov
Sanmina-SCI Systems Singapore Pte. Ltd.SINGAPORE North East, Singapore7000api.fda.gov
Univac Precision Engineering Pte LtdSingapore North West, Singapore2000api.fda.gov
Vivo Surgical Private LimitedSingapore South West, Singapore1000api.fda.gov
Yixin Precision Engineering Pte LtdSINGAPORE Central Singapore, Singapore1000api.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.