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Data / Medical devices / China / Jiangsu Caina Medical Co., Ltd

Jiangsu Caina Medical Co., Ltd: FDA-registered device maker in Jiangyin Jiangsu, China, 11 510(k) clearances

Jiangsu Caina Medical Co., Ltd is registered with the FDA (registration 3005670221) in Jiangyin Jiangsu, China. It lists 20 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 7, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
3005670221
Address
No.23, Huanxi Road, Zhutang Town, Jiangyin Jiangsu, China, 214415
Owner or operator
Jiangsu Caina Medical Co., Ltd (10038768)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
January 14, 2016
Registered through
2026
Brand names listed
BLUNT CANNULA, Blood Collection Needle with/without Holder, Blood Collection Tube Holder, Disposable Sterile Needle, ENFit Oral / Enteral Syringe, ENFit Syringe,ENFit Syringe cap, ENFit Tip Irrigation Syringe, Insulin Safety Syringe and more

Devices it lists

DeviceProduct codeClassRoleSource
Anesthesia Conduction KitCAZ2Manufactureraccessdata.fda.gov
Cannula, InjectionFGY1Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Exporter to the USaccessdata.fda.gov
Enteral Syringes With Enteral Specific ConnectorsPNR2Contract manufacturer, Manufactureraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Contract manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract manufacturer, Manufactureraccessdata.fda.gov
Non-Coring (Huber) NeedlePTI2Manufactureraccessdata.fda.gov
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact QEH2Manufactureraccessdata.fda.gov
Set, Administration, IntravascularFPA2Manufactureraccessdata.fda.gov
Syringe, AntistickMEG2Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Manufactureraccessdata.fda.gov
Syringe, PistonFMF2Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufactureraccessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, ManualKST1Manufactureraccessdata.fda.gov
System, Suction, Lipoplasty For RemovalQPB2Manufactureraccessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or IntubationFEG2Contract manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Contract manufactureraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Manufactureraccessdata.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
March 7, 2024K232781Safety Sliding Blood Collection SetJKASubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
June 2, 2023K230635Pen NeedleFMISubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
July 21, 2022K220184Pump Alignment SyringeFMFSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
April 7, 2021K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTISubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
February 12, 2021K201356Plastic LOR SyringeCAZSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
September 9, 2020K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample AdapterJKASubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
July 17, 2020K193526Syringe with safety needle, Safety needleFMFSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
October 3, 2019K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy SyringeMEGSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
August 6, 2019K190502ENFit Oral / Enteral SyringePNRSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
December 14, 2018K181374NRFit SyringeQEHSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
June 14, 2018K172938Disposable Sterile NeedleFMISubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov

Compare with other makers

Updated March 7, 2024. 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.