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Data / Medical devices / Hong Kong

Medical device makers in Hong Kong: 134 FDA-registered establishments

134 establishments in Hong Kong are registered with the FDA to make medical devices for the US market, listing 297 device types. 39 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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  • Hong KongCountry

Device types made here

Device types with the most registered makers in this country.

DeviceProduct codeMakers
Sunglasses (Non-Prescription Including Photosensitive)HQY45
Frame, SpectacleHQZ43
Spectacle, MagnifyingHOI37
Lens, Spectacle, Non-Custom (Prescription)HQG15
Massager, Therapeutic, ElectricISA13
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY10
Toothbrush, ManualEFW8
Accessory, Surgical ApparelLYU7
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ6
Unit, Syringe, Air And/Or WaterECB6
Toothbrush, PoweredJEQ6
Restoration, PorcelainNSP5
Restoration, Porcelain-Fused-To-MetalNSO5
Restoration, Noble MetalNSJ5
Laser, Comb, HairOAP5
Powered Laser Surgical InstrumentGEX4
Guide, Needle, SurgicalGDF4
Marker, SkinFZZ4
Floss, DentalJES4
Monitor, Bed PatientKMI4
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaQKR4
Disinfectant, Medical DevicesLRJ4
Scraper, TongueLCN4
Dentures, PartialNSK4
Device, Pressure ApplyingKNM4
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot UlcersPZL4
Restoration, Base MetalNSQ4
Powered Surgical Instrument For Improvement In The Appearance Of CelluliteOUP4
Stimulator, Muscle, PoweredIPF4
Gas, Laser GeneratingNXF4
Colonic Irrigation SystemKPL4
Acetylcholine Chloride, Specific Reagent For Pseudo CholinesteraseDLI4
Accessories, Implant, Dental, EndosseousNDP3
Mask, SurgicalFXX3
Lamp, Infrared, Therapeutic HeatingILY3
Bed, ManualFNJ3
Unit, Oral IrrigationEFS3
Pack, Hot Or Cold, ReusableIME3
Pick, MassagingJET3
Dentures, FullNSL3
Calculator/Data Processing Module, For Clinical UseJQP3
Lens, Spectacle (Prescription), For Reading DiscomfortNJH3
Irrigator, Powered NasalKMA3
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2
Instrument, Manual, Surgical, General UseMDM2
Retainer, MatrixJEP2
Electrode, ElectrosurgicalJOS2
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY2
Transducer, Ultrasonic, DiagnosticITX2
Tape And Bandage, AdhesiveKGX2
Accessories, Cleaning Brushes, For EndoscopeMNL2
Mask, ScavengingKHA2
Syringe, Restorative And Impression MaterialEID2
Cup, ProphylaxisEHK2
Mirror, MouthEAX2
Mouthpiece, Saliva EjectorDYN2
Dispenser, Solid MedicationNXB2
Dressing, CompressionMHW2
Non-Surgical GownOEA2
Garment, Protective, For IncontinenceEYQ2
Tray, Impression, PreformedEHY2
Vibrator, TherapeuticIRO2
Pad, Heating, PoweredIRT2
Unit, Heating, PoweredIRQ2
Cable, ElectrodeIKD2
Endoscope Channel AccessoryODC2
Orthosis, LumbarIQE2
Joint, Knee, External BraceITQ2
Scale, PatientFRW2
Endoscopic Bite BlockMNK2
Light Based Over The Counter Wrinkle ReductionOHS2
Over-The-Counter Powered Light Based Laser For AcneOLP2
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2
Powered Light Based Non-Laser Surgical Instrument With Thermal EffectONF2
Heat Source For Bleaching TeethEEG2
Strip, Polishing AgentEHM2
Eraser, Dental StainMAU2
Stocking, Medical Support (For General Medical Purposes)FQL2
Orthosis, Limb BraceIQI2
Alloy, Metal, BaseEJH2
Joint, Ankle, External BraceITW2
Brush, Dermabrasion, PoweredGFE2
Wheel, Polishing AgentEJQ2
Handpiece, Contra- And Right-Angle Attachment, DentalEGS2
Devices, Breath Trapping, AlcoholDJZ2
Prosthesis, OrthodonticNSR2
Components, ExerciseIOD2
Ring, Teething, Fluid-FilledKKO2
Bottle, Collection And Trap, Breathing System (Uncalibrated)CBC2
Scale, Stand-On, PatientFRI2
Selector, Color, Spectacle, Lens, TintNFD2
Restoration, Resin, Crown And BridgeNSN2
Protector, Hearing (Insert)EWD2
Syringe, PistonFMF1
Laparoscope, General & Plastic SurgeryGCJ1
ArthroscopeHRX1
ReamerHTO1
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1
Needle, Hypodermic, Single LumenFMI1

Makers in Hong Kong

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

MakerLocationDevice types510(k) clearancesPMA approvalsRecall eventsSource
Vincent Medical Manufacturing. Co., Ltd.Kowloon, Hong Kong452100api.fda.gov
Modern Medical Equipment Manufacturing, Ltd.Kwai Chung, N.T., Hong Kong261900api.fda.gov
Ga Health Company LimitedHong Kong, Hong Kong111401api.fda.gov
Quasar Engineering Ltd.Kowloon, Hong Kong51000api.fda.gov
Truly Instrument LimitedKwai Chung, Hong Kong31000api.fda.gov
U&u Medical Technology Co., Ltdhongkong, Hong Kong131000api.fda.gov
Warrenslove(hongkong)limitedKowloon, Hong Kong141000api.fda.gov
Hong Kong Lute Technology Co., LimitedHong Kong, Hong Kong27800api.fda.gov
Duplex International Trading LimitedHong Kong, Hong Kong6600api.fda.gov
Tyece LimitedKowloon, Hong Kong4600api.fda.gov
Kenpax International LimitedKowloon, Hong Kong5500api.fda.gov
LCCS Products LimitedSai Ying Pun, Hong Kong6500api.fda.gov
Premium Plus International LimitedHong Kong, Hong Kong28500api.fda.gov
Tens Plus Industrial Co.Hong Kong, Hong Kong3500api.fda.gov
China 1 Link, LtdMongkok Kowloon, Hong Kong5400api.fda.gov
Li Wai Precision International LimitedTsimshatsui, Kowloon, Hong Kong28400api.fda.gov
Anker Innovations LimitedHong Kong, Hong Kong1300api.fda.gov
Digital Dental Depot LimitedHong Kong, Hong Kong16300api.fda.gov
Blue Sail (hong Kong) Trading LimitedHarbour, Hong Kong13200api.fda.gov
Belun Technology Company LimitedNew Territories, Hong Kong2200api.fda.gov
Hong Kong Lanli Technology Co., LimitedTuen Mun, Hong Kong2200api.fda.gov
Skypro Medical Supplies CompanyHong Kong, Hong Kong2200api.fda.gov
3H Apotheke LimitedHong Kong, Hong Kong20100api.fda.gov
Direcsource LimitedHong Kong, Hong Kong13100api.fda.gov
Fook Tin Technologies LimitedQuarry Bay, Hong Kong2100api.fda.gov
Gorgeous Beauty Equipment Manufacture LimitedHong Kong, Hong Kong17100api.fda.gov
Green Island International TCM Group LimitedHk, Hong Kong2100api.fda.gov
Hebei Mita Biotechnology LimitedHong Kong, Hong Kong16100api.fda.gov
Hebei Mita Technology LimitedHong Kong, Hong Kong18100api.fda.gov
Hong Kong Etech Groups LimitedHongkong, Hong Kong7100api.fda.gov
Hopstech Industries LtdKwun Tong, Kowloon, Hong Kong, Hong Kong5100api.fda.gov
Intco Medical International (hong Kong) Co., LimitedHong Kong, Hong Kong1100api.fda.gov
Oman Medical Beauty Manufacture LimitedHong Kong, Hong Kong18100api.fda.gov
P L Overseas LimitedHong Kong, Hong Kong2100api.fda.gov
Pacific Care Limited / Pacificare Asia LimitedHong Kong, Hong Kong19100api.fda.gov
Phase Scientific International LimitedShatin NT, HONG KONG, Hong Kong5101api.fda.gov
Savewo LimitedNew Territories, Hong Kong5100api.fda.gov
Shokz Health Global LimitedKowloon, Hong Kong1100api.fda.gov
SML Med-Tech Solutions LimitedHong Kong, Hong Kong6100api.fda.gov
A&a Product Manufacturing LimitedShaTin,New Territories, Hong Kong2000api.fda.gov
Alleva Medical LtdShatin, N.T., Hong Kong1000api.fda.gov
Allied Group Development LimitedTsuen Wan, N.T., Hong Kong3000api.fda.gov
Argus Vision Intl. Ltd.Wan Chai, Hong Kong, Hong Kong7000api.fda.gov
Arts Optical Company LimitedKowloon, Hong Kong4000api.fda.gov
AusMed Global LimitedHong Kong, Hong Kong1000api.fda.gov
BestwayKowloon, HongKong, Hong Kong1000api.fda.gov
Billion Excel Optical Manufactory Company LimitedHong Kong, Hong Kong2000api.fda.gov
Brilivision MFG., Ltd.Kowloon, Hong Kong2000api.fda.gov
BsenseCentral, Hong Kong1000api.fda.gov
Betamars (HK) International, Ltd.Hong Kong, Hong Kong6000api.fda.gov
Booguu Company LimitedPak Shek Kok, N.T., Hong Kong1000api.fda.gov
C-Mer Rainsoptics LimitedHong Kong, Hong Kong1000api.fda.gov
C4 Development LimitedKwun Tong, Hong Kong2000api.fda.gov
Cerie International LimitedHong Kong, Hong Kong2000api.fda.gov
Commonwealth Optical Manufactory Ltd.Kowloon, Hong Kong3000api.fda.gov
Concept Eyewear Manufacturer Ltd.Kwun Tong, Kowloon, Hong Kong3000api.fda.gov
Creative China Creations LtdHong Kong, Hong Kong7000api.fda.gov
Cressida Origin Field Co.,limitedKowloon, Hong Kong3000api.fda.gov
D.I. Ware CompanyHong Kong, Hong Kong3000api.fda.gov
Dragon Eyes Hong Kong LimitedCheung Sha Wan, Kowloon, Hong Kong3000api.fda.gov
Defond Electech Co., LtdDongguan, Hong Kong1000api.fda.gov
Eagle Intl. (industrial) Ltd.Hong Kong, Hong Kong3000api.fda.gov
EksKowloon, Hong Kong2000api.fda.gov
Elegance Optical Manufactory Ltd.Kowloon, Hong Kong, Hong Kong3000api.fda.gov
Eye Fashion Co. Ltd.Kwai Chung, Hong Kong3000api.fda.gov
Eyestar LimitedKwun Tong, KOWLOON, Hong Kong3000api.fda.gov
Eastern Progress Plastic & Electronic Manufactory Co., Ltd.Dongguan, Guangdong, Hong Kong3000api.fda.gov
F-Six Dental Technology Co.,limitedCentral Hong Kong, Hong Kong12000api.fda.gov
FC Company LtdHong kong, Hong Kong1000api.fda.gov
Framework Development LimitedKwai Chung, N.T., Hong Kong3000api.fda.gov
Golden Aim International LtdShenzhen City,, GUANGDONG, CHINA, Hong Kong7000api.fda.gov
Green Breeze LimitedCentral, Hong Kong1000api.fda.gov
Greenwell Health Care (HK) LtdTsuen Wan, Hong Kong1000api.fda.gov
Greyland Trading LtdTsim Sha Tsui, Hong Kong1000api.fda.gov
Good Quality Optical Company LimitedKwai Chung, N.T., Hong Kong3000api.fda.gov
H.K. Chaoxin Optical Co. Ltd.Tsuen Wan, Hong Kong4000api.fda.gov
HK Advanced Dental Digital LimitedTsuen Wan, N.T, Hong Kong7000api.fda.gov
Hong Kong Optical Lens Co., Ltd.Kwun Tong, Kowloon, Hong Kong3000api.fda.gov
Hong Wan Eyewear Design & Manufacturing LimitedHong Kong, Hong Kong3000api.fda.gov
Hongkong DS Dental Technology Co. LimitedTung Chung Lantau, Hong Kong7000api.fda.gov
Hopeful Rubber Manufacturing Co.New Territories , Hong Kong, Hong Kong1000api.fda.gov
I-Glasses Ltd.Kowloon, Hong Kong3000api.fda.gov
Ialin Optical MFG., (H.K.) Co. Ltd.Cheung Sha Wan, Hong Kong4000api.fda.gov
Id EyewearHong Kong, Hong Kong1000api.fda.gov
Innovance Textiles LimitedHong Kong, Hong Kong3000api.fda.gov
Icare (Hong Kong) Company LimitedHong Kong, Hong Kong3000api.fda.gov
J&C Supply-Chains Trade LimitedHk, Hong Kong3000api.fda.gov
Jasan International LimitedHong Kong, Hong Kong18000api.fda.gov
JT Tech Electronics (hong Kong) Co LtdHong Kong, Hong Kong2000api.fda.gov
Just Eyewear (MFG) Co. LimitedHong Kong, Hong Kong4000api.fda.gov
Kaizen Dynamic LimitedHong Kong, Hong Kong2000api.fda.gov
Kelfred Optical Ltd.Shatin, N.T., Hong Kong4000api.fda.gov
Kent-Tech Manufacturers LimitedHong Kong, Hong Kong1000api.fda.gov
Kin Sun Industrial Ltd.Kowloon, Hong Kong3000api.fda.gov
Kingsong Co. Ltd.Kwai Chung, Hong Kong2000api.fda.gov
Lancer Optical LimitedTsuen Wan, New Territories, Hong Kong5000api.fda.gov
Lik Sang Optical FactoryFotan, Hong Kong2000api.fda.gov
Mazen Group LimitedHunghom, Kowloon, Hong Kong4000api.fda.gov
Medical Devices Group LimitedN.T., Hong Kong2000api.fda.gov
Micron Eyewear Manufactory Co., Ltd.Hung Hom, Kowloon,, Hong Kong3000api.fda.gov
Mixen Company LimitedKowloon, Hong Kong1000api.fda.gov
Marvelworks Ltd.Chai Wan, Hong Kong1000api.fda.gov
Ocean Eyewear (hong Kong) Ltd.Hong Kong, Hong Kong2000api.fda.gov
Odd Skin Out LtdHong Kong, Hong Kong3000api.fda.gov
Okia Optical Co., Ltd.Kowloon, Hong Kong13000api.fda.gov
Pacific Data Intl. Ltd.Kowloon, Hong Kong3000api.fda.gov
Polette LimitedHong Kong, Hong Kong9000api.fda.gov
Premier Optical Mfy. Ltd.Kowloon Bay, Hong Kong4000api.fda.gov
Refined Manufacturing LtdHong Kong, Hong Kong1000api.fda.gov
Regal Prosthesis LimitedKwai Chung NT, Hong Kong5000api.fda.gov
Rehab-Robotics Company LimitedHong Kong, Hong Kong1000api.fda.gov
Relegend Eyewear Co., Ltd.Lai Chi Kok, Kowloon,, Hong Kong4000api.fda.gov
Rondish Company LimitedKwai Chung, Nt, Hong Kong, Hong Kong1000api.fda.gov
Samson Innovation Corp. Ltd.Kowloon, Hong Kong10000api.fda.gov
Sky HKMC International LimitedHong Kong, Hong Kong8000api.fda.gov
Stepper Eyewear LimitedKowloon, Hong Kong4000api.fda.gov
Stilo Optical Technology (HK) Co., Limited.Tsuen Wan, N.T., Hong Kong3000api.fda.gov
STL Electronics LtdKwai Chung, Hong Kong2000api.fda.gov
Sun Hing Optical Manufactory Ltd.Kwun Tong, Hong Kong4000api.fda.gov
Sunta Optical Co., Ltd.Hong Kong, Hong Kong3000api.fda.gov
Suqian Zhengtong Medical Instruments Co. LtdChina, Hong Kong27000api.fda.gov
Talentone Hong Kong LimitedKowloon,Hong Kong, Hong Kong4000api.fda.gov
Techtronic Trading Co LtdKwai Chung New Territories, Hong Kong, Hong Kong3000api.fda.gov
Tohkai Precision International Ltd.Kwun Tong, Kowloon, Hong Kong4000api.fda.gov
Trinity Optical Manufactory LtdSan Po Kong, Kowloon, Hong Kong3000api.fda.gov
TVP Developments LtdKowloon, Hong Kong7000api.fda.gov
Uf Accessories Co., LimitedSheung Wan, Hong Kong4000api.fda.gov
Uni Precision Industrial Ltd.Kowloon, Hong Kong1000api.fda.gov
United Creation Optical Co.,ltdKowloon Bay, Kowloon, Hong Kong4000api.fda.gov
V-Best Dental Technology LimitedKwun Tong, Hong Kong1000api.fda.gov
Wah Ming Optical Mfy. Ltd.Kowloon, Hong Kong, Hong Kong3000api.fda.gov
Win-Win Optics Co., LimitedHong Kong, Hong Kong5000api.fda.gov
World Dentists Association America LimitedTsim Sha, Hong Kong8000api.fda.gov
Yao Yang Eyewear Company LimitedKwai Chung, Hong Kong3000api.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.