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Data / Medical devices / China / Amsino Medical (kunshan) Co., Ltd.

Amsino Medical (kunshan) Co., Ltd.: FDA-registered device maker in KUNSHAN CITY Jiangsu, China, 21 510(k) clearances

Amsino Medical (kunshan) Co., Ltd. is registered with the FDA (registration 3005669815) in KUNSHAN CITY Jiangsu, China. It lists 54 device types. The FDA files 21 510(k) clearances under its listings, the newest dated October 7, 2022. 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 Amsino Medical (kunshan) Co., Ltd.
FDA registration number
3005669815
Address
582 Shipu Lidu Road, Qiandeng Town, KUNSHAN CITY Jiangsu, China, 215343
Owner or operator
AMSINO MEDICAL (KUNSHAN) CO., LTD. (9086542)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
May 1, 2006
Registered through
2026
Brand names listed
5 in 1 connector, AMSINO IV Extension Set, AMSINO TRACHEOSTOMY CARE TRAY, AMSINO Vaginal Speculum, AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE, AMSURE NEBULIZER, AMSafe IV Extension Set, AMSafe NeuFlo Needleless Connector and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Manufactureraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Manufactureraccessdata.fda.gov
Appliance, Colostomy, DisposableEZS1Contract manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Basin, EmesisFNY1Contract manufactureraccessdata.fda.gov
Bath, Sitz, NonpoweredKTC1Contract manufacturer, Manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter Care TrayOHR2Contract manufactureraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Contract manufactureraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Manufactureraccessdata.fda.gov
Catheter, StraightEZD2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, Ureteral, Gastro-UrologyEYB2Manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Contract manufacturer, Manufactureraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Contract manufacturer, Manufactureraccessdata.fda.gov
Connector, CatheterGCD1Manufactureraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Contract manufacturer, Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Occlusion, UmbilicalFOD1Manufactureraccessdata.fda.gov
Device, Urine Flow Rate Measuring, Non-Electrical, DisposableFFG2Contract manufacturer, Manufactureraccessdata.fda.gov
Douche Apparatus, Vaginal, TherapeuticHED1Contract manufactureraccessdata.fda.gov
Dressing, Wound, DrugFROUManufactureraccessdata.fda.gov
Enema KitFCE1Contract manufacturer, Manufactureraccessdata.fda.gov
Enteral Administration Kit (Adult & Pediatric)PRM2Contract manufacturer, Manufactureraccessdata.fda.gov
Enteral Syringes With Enteral Specific ConnectorsPNR2Manufactureraccessdata.fda.gov
Foley Catheter Kit (Excludes Hiv Testing)PPB2Contract manufactureraccessdata.fda.gov
ForcepsHTD1Contract manufacturer, Manufactureraccessdata.fda.gov
General Surgery TrayLRO2Contract manufacturer, Manufactureraccessdata.fda.gov
I.V. Start KitLRS2Manufactureraccessdata.fda.gov
Irrigation Kit (Wounds)PXY1Contract manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Contract manufacturer, Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Contract manufacturer, Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract manufacturer, Manufactureraccessdata.fda.gov
Pump, Infusion, EnteralLZH2Specification developeraccessdata.fda.gov
Saline, Vascular Access FlushNGT2Manufacturer, Specification developeraccessdata.fda.gov
Set, Administration, IntravascularFPA2Contract manufacturer, Manufactureraccessdata.fda.gov
Shield, NippleHFS1Contract manufactureraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Contract manufacturer, Manufactureraccessdata.fda.gov
Suture Removal KitMCZ1Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Contract manufacturer, Manufactureraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Contract manufacturer, Manufactureraccessdata.fda.gov
Tracheobronchial Suction Catheter KitOFR1Contract manufactureraccessdata.fda.gov
Trap, Sterile SpecimenBYZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)FCM2Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Contract manufacturer, Manufactureraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Manufactureraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Contract manufacturer, Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov
Urinary Irrigation KitPPF2Contract manufactureraccessdata.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
October 7, 2022K220267AMSafe NeuFlo Needleless ConnectorFPASubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
March 22, 2022K213522AMSafe Pre-Filled Normal Saline Flush SyringeNGTSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
September 25, 2020K200051PUGGLE Enteral Feeding Pump and Feeding SetLZHSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
July 12, 2019K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGTSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
September 7, 2018K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushFROSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
September 5, 2018K173665AMSafe Sure-Lok Needle-Free ConnectorFPASubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
September 4, 2018K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterEZLSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
March 30, 2018K171857AMSure® Enteral Feeding Syringe with ENFit TipPNRSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
September 29, 2010K101958AMSINO I.V. ADMINISTRATION AND EXTENSION SETSFPASubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
March 10, 2010K093773AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETSFPASubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
August 21, 2009K091306AMSURE PVC INTERMITTENT CATHETEREZDSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
December 19, 2007K070873AMSURE BLADDER IRRIGATION SETLJHSubstantially EquivalentAmsino Intl., Inc.accessdata.fda.gov
October 1, 2007K070411AMSURE NEBULIZERCAFSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
June 29, 2006K061039AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLEFMFSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
May 2, 2005K050656AMSINO SUTURE REMOVAL KITMCZSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
May 2, 2005K050654AMSINO I.V. START KITLRSSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
February 4, 2004K030293AMSURE RED RUBBER URETHRAL CATHETEREYBSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
May 23, 2003K030664AMSURE FOLEY INSERTION TRAYFCMSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
December 9, 2002K023276AMSINO TRACHEOSTOMY CARE TRAYLROSubstantially EquivalentAmsino International, Inc.accessdata.fda.gov
January 12, 2000K992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKEKNTSubstantially EquivalentAmsino Intl., Inc.accessdata.fda.gov
May 11, 1995K951528AMSINO DISPOSABLE VIGINAL SPECULUMHIBSubstantially EquivalentAmsino Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated October 7, 2022. 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.