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Data / Medical devices / Indonesia

Medical device makers in Indonesia: 61 FDA-registered establishments

61 establishments in Indonesia are registered with the FDA to make medical devices for the US market, listing 163 device types. 23 have a 510(k) clearance or PMA approval on file and 0 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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  • IndonesiaCountry

Device types made here

Device types with the most registered makers in this country.

DeviceProduct codeMakers
Polymer Patient Examination GloveLZA12
Medical Glove, SpecialtyLZC10
Fentanyl And Other Opioid Protection GloveQDO9
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ9
Latex Patient Examination GloveLYY7
Orthosis, Corrective ShoeKNP5
Tape And Bandage, AdhesiveKGX4
Splint, Hand, And ComponentsILH3
Blood Pressure CuffDXQ3
Sunglasses (Non-Prescription Including Photosensitive)HQY3
Spectacle, MagnifyingHOI3
Frame, SpectacleHQZ3
Syringe, PistonFMF2
Needle, Hypodermic, Single LumenFMI2
Dressing, Wound, HydrophilicNAC2
Applicator, Absorbent Tipped, Non-SterileKXF2
Gauze / Sponge,Nonresorbable For External UseNAB2
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY2
Bedding, Disposable, MedicalKME2
Fiber, Medical, AbsorbentFRL2
Dressing, Wound, OcclusiveNAD2
Catheter And Tip, SuctionJOL2
Infusor, Pressure, For I.V. BagsKZD2
Cable, ElectrodeIKD2
Bed, Ac-Powered Adjustable HospitalFNL2
Surgeon'S GlovesKGO2
Protector, Skin PressureFMP2
Device, Transfer, Patient, ManualFMR2
Lens, Spectacle, Non-Custom (Prescription)HQG2
Pad, Alcohol, Device DisinfectantLKB2
Joint, Ankle, External BraceITW2
Support, ArmIOY2
Laparoscope, General & Plastic SurgeryGCJ1
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH1
Stimulator, NerveETN1
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH1
Accessory, Surgical ApparelLYU1
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOIY1
Dress, SurgicalFYE1
Enzyme Immunoassay, PhencyclidineLCM1
Slide Stainer, AutomatedKPA1
Glucose Dehydrogenase, GlucoseLFR1
System, Test, Blood Glucose, Over The CounterNBW1
Device, Intravascular Catheter SecurementKMK1
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ1
Set, Administration, IntravascularFPA1
Electrode, NeedleGXZ1
Filters, Cell Collection, Tissue ProcessingKET1
Syringe, Irrigating (Non Dental)KYZ1
Scissors, General, SurgicalLRW1
Lenses, Soft Contact, Daily WearLPL1
Lenses, Soft Contact, Extended WearLPM1
Accessory, Assisted Reproduction, ExemptPUB1
Sleeve, Limb, CompressibleJOW1
Drape, Surgical, ExemptPUI1
Sling, ArmILI1
Stethoscope, ManualLDE1
Stand, InfusionFOX1
Container, Liquid Medication, GraduatedKYW1
Syringe, Periodontic, Endodontic, IrrigatingEIC1
Container, Specimen, Non-SterileNNI1
Lubricant, PatientKMJ1
Chair, Blood DonorFML1
Toothbrush, PoweredJEQ1
Pack, Hot Or Cold, DisposableIMD1
Stool, Operating-RoomFZM1
Toothbrush, ManualEFW1
Bandage, ElasticFQM1
Laryngoscope, RigidCCW1
Pad, Heating, PoweredIRT1
Lamp, Infrared, Therapeutic HeatingILY1
Forceps, Tooth Extractor, SurgicalEMG1
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG1
Electrocardiograph, Ambulatory, With Analysis AlgorithmMLO1
Tubing, Pressure And AccessoriesBYX1
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT1
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX1
Cannula, Nasal, OxygenCAT1
Tubing, NoninvasiveGAZ1
Cannula, OphthalmicHMX1
Light, Examination, Medical, Battery PoweredKYT1
Table, Operating-Room, ElectricalGDC1
Cabinet, Table And Tray, AnesthesiaBRY1
Bed, ManualFNJ1
Feeding Tube KitPRR1
System, Measurement, Blood-Pressure, Non-InvasiveDXN1
Orthosis, LumbarIQE1
Joint, Knee, External BraceITQ1
Gown, SurgicalFYA1
Container, Specimen, SterileFMH1
Device, Occlusion, UmbilicalFOD1
Orthosis, Cervical-Thoracic, RigidIQF1
Saline, Vascular Access FlushNGT1
Pad, Menstrual, UnscentedHHD1
Unit, Oral IrrigationEFS1
Disinfectant, Medical DevicesLRJ1
Orthosis, Lumbo-SacralIPY1
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH1
Stimulator, Muscle, Powered, For Muscle ConditioningNGX1
Chair And Table, MedicalKMN1

Makers in Indonesia

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

MakerLocationDevice types510(k) clearancesPMA approvalsRecall eventsSource
PT. Medisafe TechnologiesKab. Deli Serdang Sumatera Utara, Indonesia62600api.fda.gov
Arista Latindo Industrial, Ltd. P.T.Jakarta Barat, Indonesia32400api.fda.gov
PT. Ciba Vision BatamBATAM ISLAND Riau, Indonesia13640api.fda.gov
Pt.shamrock Manufacturing Corp.MEDAN Sumatera Utara, Indonesia5900api.fda.gov
P.T. Maja Agung LatexindoSUNGGAL DELI SERDANG Sumatera Utara, Indonesia4700api.fda.gov
PT Newpoint TechnologySimalungun Sumatera Utara, Indonesia4400api.fda.gov
PT. Nipro Indonesia JayaKarawang Jawa Barat, Indonesia4400api.fda.gov
PT Basic International SumateraSimalungun Regency Sumatera Utara, Indonesia4300api.fda.gov
PT Greatview TechnologiesSimalungun Sumatera Utara, Indonesia4300api.fda.gov
PT K-Tech IndustriesSimalungun Sumatera Utara, Indonesia4300api.fda.gov
PT. Intan Hevea IndustryMEDAN Sumatera Utara, Indonesia1300api.fda.gov
PT. Team Metal IndonesiaBATAM Riau, Indonesia4300api.fda.gov
PT. Universal GlovesMEDAN Sumatera Utara, Indonesia2300api.fda.gov
PT Healthguard TechnologiesSimalungun Sumatera Utara, Indonesia4200api.fda.gov
PT NSP Technology BatamBatu Ampar Riau, Indonesia2200api.fda.gov
PT Ywanjan TechnologyPelalawan Regency Riau, Indonesia4200api.fda.gov
PT Alpha Medical TechnologyKota Depok Jawa Barat, Indonesia1100api.fda.gov
PT Dongbang Medical IndonesiaPekalongan Jawa Tengah, Indonesia1100api.fda.gov
PT Oneject IndonesiaKab Bekasi Jawa Barat, Indonesia1100api.fda.gov
PT. Haloni JaneCIKUPA, TANGERANG Banten, Indonesia1100api.fda.gov
PT. Sintong Unigolden GloveKISARAN Sumatera Utara, Indonesia4100api.fda.gov
Sugih Instrumendo Abadi, PTBandung Barat Jawa Barat, Indonesia5100api.fda.gov
Technomed Asia, PT.Bandung Jawa Barat, Indonesia6100api.fda.gov
Multi Garmen IndonesiaBOGOR Jawa Barat, Indonesia15000api.fda.gov
P.T. Sankei Medical IndustriesCIKANDE SERANG Banten, Indonesia2000api.fda.gov
P.T. Vision Ease AsiaLIPPO CIKARANG-BEKASI Jakarta, Indonesia1000api.fda.gov
PT Ace Medical Products IndonesiaKedawung, Banyuputih, Batang Regency, Jawa Barat, Indonesia9000api.fda.gov
PT Food Packaging JayaIndramayu Jawa Barat, Indonesia1000api.fda.gov
PT Geomed IndonesiaSEMARANG Jawa Tengah, Indonesia2000api.fda.gov
PT Graha Elektrindo PerkasaKota Tangerang Banten, Indonesia4000api.fda.gov
PT Giken Precision IndonesiaBatam Riau, Indonesia2000api.fda.gov
PT Indonesia Fullcare MedicalBatang Jawa Tengah, Indonesia2000api.fda.gov
PT JMS BatamBATAM Kepulauan Riau, Indonesia5000api.fda.gov
PT Kepler Signaltek IndonesiaBatam Kepulauan Riau, Indonesia1000api.fda.gov
PT Medlinket Medical IndonesiaBatam Kepulauan Riau, Indonesia1000api.fda.gov
PT Newlife Healthcare InternationalKota Administrasi Jakarta Utara, Indonesia9000api.fda.gov
PT OSI ElectronicsBatam Centre Riau, Indonesia2000api.fda.gov
PT PHC IndonesiaCikarang Barat Bekasi Jawa Barat, Indonesia7000api.fda.gov
PT Philips Industries BatamMuka Kuning, Batam Riau, Indonesia3000api.fda.gov
PT Sinergy Product SolutionKabupaten Mojokerto Jawa Timur, Indonesia1000api.fda.gov
PT Suma Artha PerkasaTangerang Banten, Indonesia4000api.fda.gov
PT Top-Point MedicalKabupaten Bogor Jawa Barat, Indonesia1000api.fda.gov
PT Vitanova Medical IndonesiaKec. Cikarang Pusat, Kab. Bekasi Jawa Barat, Indonesia2000api.fda.gov
PT Youmi Medika IndustriBatang Sulawesi Utara, Indonesia4000api.fda.gov
PT. Astron Lensindo NusaTangerang City Banten, Indonesia5000api.fda.gov
PT. Beurer Indonesia TechnologyKab Kendal Jawa Tengah, Indonesia6000api.fda.gov
PT. Cipta Karya BuanaSidoarjo Jawa Timur, Indonesia1000api.fda.gov
PT. GagacloSemarang Jawa Tengah, Indonesia5000api.fda.gov
PT. Hisamitsu Pharma IndonesiaSidoarjo Jawa Timur, Indonesia1000api.fda.gov
PT. Jayamas Medica Industri TBKJombang Jawa Timur, Indonesia14000api.fda.gov
PT. Jayamas Wellong MedicalKab. Jombang Jawa Timur, Indonesia6000api.fda.gov
PT. Jayamas Medica Industri TbkSidoarjo Jawa Timur, Indonesia11000api.fda.gov
PT. KH InternationalJakarta Utara, Indonesia1000api.fda.gov
PT. Mega Andalan KalasanJOGYAKARTA Yogyakarta, Indonesia17000api.fda.gov
PT. Paramount Bed IndonesiaGANDAMEKAR, CIKARANG BARAT, BEKASI Jawa Barat, Indonesia1000api.fda.gov
PT. Parkland World Indonesia 2Serang Banten, Indonesia1000api.fda.gov
PT. Seng Dam Jaya AbadiMojokerto Jawa Timur, Indonesia1000api.fda.gov
PT. SP ManufacturingBatam Riau, Indonesia1000api.fda.gov
PT. Sukses Abadi IndonesiaKabupaten Nganjuk Jawa Timur, Indonesia1000api.fda.gov
Sakiteya Medical IndonesiaCentral Jawa, Indonesia4000api.fda.gov
VARTA Microbattery (Indonesia)Batam, KEPRI Riau, Indonesia1000api.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.