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Data / Medical devices / China / Hangzhou Fushan Medical Appliance Co., Ltd.

Hangzhou Fushan Medical Appliance Co., Ltd.: FDA-registered device maker in Hangzhou City Zhejiang, China, 7 510(k) clearances

Hangzhou Fushan Medical Appliance Co., Ltd. is registered with the FDA (registration 3006787036) in Hangzhou City Zhejiang, China. It lists 44 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 11, 2005. 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.

Get makers like this oneWatch Hangzhou Fushan Medical Appliance Co., Ltd.
FDA registration number
3006787036
Address
No.1288 South Jinxi Road, Linglong Industrial Park Lin'an District, Hangzhou City Zhejiang, China, 311301
Owner or operator
Hangzhou Fushan Medical Appliance Co., Ltd. (10022911)
Roles
Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler, Reprocessor
First device listed
October 21, 2007
Registered through
2026
Brand names listed
Amsino Silicone Catheter, BOTTLE, Balloon Catheter,Silicone, Bitewing Tabs, CATHETER DRESSING, Catheter Fixing dressing, Central Venous Catheter Dressing, Chest Drainage Kit and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Ureteral CatheterEYI1Contract manufacturer, Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufacturer, Manufactureraccessdata.fda.gov
Anoscope And AccessoriesFER2Contract manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Contract manufactureraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
Balloon, EpistaxisEMX1Contract manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Contract manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, Balloon TypeGBA1Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Drainage, Intraoral/ExtraoralOAJ1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Catheter, IrrigationGBX1Exporter to the US, Manufacturer, Reprocessoraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Catheter, Ventricular, General & Plastic SurgeryGBS1Contract manufactureraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Contract manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Repackager or relabeleraccessdata.fda.gov
Endoscope Channel AccessoryODC2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract manufactureraccessdata.fda.gov
Holder, Film, X-RayEGZ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Laryngoscope, RigidCCW1Contract manufactureraccessdata.fda.gov
Lubricant, PatientKMJ1Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Contract manufacturer, Contract sterilizer, Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Repackager or relabeleraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Repackager or relabeleraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Contract manufactureraccessdata.fda.gov
Protector, OstomyEXE1Contract manufactureraccessdata.fda.gov
Pump, Breast, Non-PoweredHGY1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Retractor, VaginalHDL1Contract manufacturer, Contract sterilizeraccessdata.fda.gov
Snare, NasalKBE1Contract manufactureraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Contract manufactureraccessdata.fda.gov
Staple, ImplantableGDW2Contract manufactureraccessdata.fda.gov
Stapler, SkinQQS1Contract manufactureraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Repackager or relabeleraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Repackager or relabeleraccessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, SterileEYZ1Manufactureraccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Repackager or relabeleraccessdata.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 11, 2005K042893UNDER BUTTOCKS DRAPEKKXSubstantially EquivalentInternational Medsurg Connection, Inc.accessdata.fda.gov
April 17, 2003K030927POWDERED VINYL EXAM GLOVES, WHITELYZSubstantially EquivalentCopioumed Intl., Inc.accessdata.fda.gov
March 10, 2003K023808IRRIGATION SETSLJHSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
November 7, 2002K022159PISTON SYRINGE & HYPODERMIC NEEDLEFMFSubstantially EquivalentInternational Medsurg Connectionaccessdata.fda.gov
June 2, 2000K990519PHOENIX EPIDURAL & SPINAL NEEDLESBSPSubstantially EquivalentMyco Medical Supplies, Inc.accessdata.fda.gov
April 1, 1987K871169LUBRICATING JELLYKMJSubstantially EquivalentH & P Industries, Inc.accessdata.fda.gov
July 14, 1977K771203DISP. HYPODERMIC NEEDLEFMISubstantially EquivalentTerumo America, Inc.accessdata.fda.gov

Compare with other makers

Updated March 11, 2005. 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.