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Data / Medical devices / China / Shanghai Jpy Ion-Tech Co., Ltd.

Shanghai Jpy Ion-Tech Co., Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance

Shanghai Jpy Ion-Tech Co., Ltd. is registered with the FDA (registration 3004748528) in Shanghai, China. It lists 70 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3004748528
Address
No. 1168, Huijin Road Qingpu Industrial Zone, Shanghai, China, 201707
Owner or operator
SHANGHAI JPY ION-TECH CO., LTD. (9066119)
Roles
Contract manufacturer, Contract sterilizer, Manufacturer
First device listed
August 25, 2004
Registered through
2026
Brand names listed
2.5MM INLINE FUSION PLATE, 25MM VERSA-DIAL TAPER ADAPTOR, 3-in-1 Shaver, 4.2mm, 3-in-1 Shaver, 5mm, ACTIS COLLARED HIGH SIZE 0, ACTIS COLLARED HIGH SIZE 1, ACTIS COLLARED HIGH SIZE 10, ACTIS COLLARED HIGH SIZE 11 and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Contract sterilizeraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeLXT2Contract sterilizeraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Contract sterilizeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract sterilizeraccessdata.fda.gov
ArthroscopeHRX2Contract sterilizeraccessdata.fda.gov
Cap, Device DisinfectantQBP2Contract sterilizeraccessdata.fda.gov
Cement ObturatorLZN2Contract sterilizeraccessdata.fda.gov
Container, SharpsMMK2Contract sterilizeraccessdata.fda.gov
Dressing, Wound, DrugFROUContract sterilizeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Contract sterilizeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract sterilizeraccessdata.fda.gov
Fibrin Sealant Preparation Device MZM2Contract sterilizeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract sterilizeraccessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOQG2Contract sterilizeraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOQI2Contract sterilizeraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, CementedOQH2Contract sterilizeraccessdata.fda.gov
Lubricant, PatientKMJ1Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Contract sterilizeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract sterilizeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract sterilizeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract sterilizeraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Contract sterilizeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Contract sterilizeraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Contract sterilizeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishMAY2Contract sterilizeraccessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, PolymerKWI2Contract sterilizeraccessdata.fda.gov
Prosthesis, Elbow, Semi-Constrained, CementedJDB2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + AdditivePBI2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal BallLZY2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)JDL3Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)KWA3Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Composite/MetalKMC2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedMRA3Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedLWJ2Contract sterilizeraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO2Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY2Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile BearingNRA3Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerKRR2Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/PolymerMBV2Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOIY2Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract sterilizeraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingNJL3Contract sterilizeraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Contract sterilizeraccessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT2Contract sterilizeraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Contract sterilizeraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedMBF2Contract sterilizeraccessdata.fda.gov
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedPKC2Contract sterilizeraccessdata.fda.gov
Pump, Infusion, OphthalmicMRH2Contract sterilizeraccessdata.fda.gov
Resin, Root Canal FillingKIF2Contract sterilizeraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Contract sterilizeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract sterilizeraccessdata.fda.gov
Sheet, BurnFPY1Contract sterilizeraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Contract sterilizeraccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Contract sterilizeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract sterilizeraccessdata.fda.gov
TrabeculotomeHMZ1Contract sterilizeraccessdata.fda.gov
Transducer, Pressure, Catheter TipDXO2Contract sterilizeraccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Contract sterilizeraccessdata.fda.gov
Washer, Bolt NutHTN2Contract sterilizeraccessdata.fda.gov
Wire, Guide, CatheterDQX2Contract sterilizeraccessdata.fda.gov
Wire, SurgicalLRN2Contract sterilizeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 10, 2012K112110STERILE LUBRICATING JELLYKMJSubstantially EquivalentJianerkang Medical Dressing Companyaccessdata.fda.gov

Compare with other makers

Updated April 10, 2012. 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.