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Data / Medical devices / China / Medsource Factory,inc.

Medsource Factory,inc.: FDA-registered device maker in CHANGZHOU Jiangsu, China, 3 510(k) clearances

Medsource Factory,inc. is registered with the FDA (registration 3009512503) in CHANGZHOU Jiangsu, China. It lists 19 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 9, 2009. Registered through 2026. 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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FDA registration number
3009512503
Address
No.160 Jin Sheng Dong Lu Jintan District, CHANGZHOU Jiangsu, China, 213200
Owner or operator
MEDSOURCE FACTORY,INC. (10086559)
Roles
Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed
November 18, 2022
Registered through
2026
Brand names listed
Burn Sheet, IV start kit

Devices it lists

DeviceProduct codeClassRoleSource
Aid, TransferIKX1Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Manufactureraccessdata.fda.gov
Blood Pressure CuffDXQ2Exporter to the US, Foreign private label distributoraccessdata.fda.gov
Connector, Airway (Extension)BZA1Manufactureraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Exporter to the USaccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Manufactureraccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Exporter to the USaccessdata.fda.gov
Scissors, Medical, DisposableJOK1Manufactureraccessdata.fda.gov
Sheet, BurnFPY1Manufactureraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Manufactureraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Manufactureraccessdata.fda.gov
Valve, Non-RebreathingCBP2Manufactureraccessdata.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 9, 2009K090014CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPEDXQSubstantially EquivalentCaremate Medical Device Co., Ltd.accessdata.fda.gov
August 26, 2008K081516MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORTCBPSubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
December 22, 2005K052743DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921CBPSubstantially EquivalentDynarex Corp.accessdata.fda.gov

Compare with other makers

Updated April 9, 2009. 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.