BEUDAMED
    FDA Registration Active 🇨🇳 China

    AMSINO MEDICAL (KUNSHAN) CO., LTD.

    Reg #: 3005669815 · FEI: 3005669815 · Expires 2026
    View on FDA
    Products
    53
    Proprietary Names
    78
    Establishment Types
    4
    Classifications
    53

    Registration Details

    Registration Name
    AMSINO MEDICAL (KUNSHAN) CO., LTD.
    Registration Number
    3005669815
    FEI Number
    3005669815
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    582 SHIPU LIDU ROAD, QIANDENG TOWN
    City
    KUNSHAN CITY Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K181423

    Owner / Operator

    Firm Name
    AMSINO MEDICAL (KUNSHAN) CO., LTD.
    Operator Number
    9086542
    Address
    582 LIDU ROAD, QIANDENG TOWN, --
    City
    KUNSHAN CITY, JIANGSU PROVINCE
    State
    CN-NOTA
    Postal Code
    215343
    Country
    CN
    Correspondent
    Holiven - Ji

    US Agent

    Business Name
    AMSINO INTERNATIONAL, INC.
    Contact Name
    Richard Lee
    Address
    708 Corporate Center Dr.
    City
    Pomona
    State
    CA
    ZIP
    91768
    Country
    US
    Email
    [email protected]
    Phone
    909 6065888

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO
    Tubes, Gastrointestinal (And Accessories) KNT
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Enema Kit FCE
    Catheter, Straight EZD
    Set, Administration, Intravascular FPA
    Bottle, Collection, Vacuum KDQ
    Speculum, Vaginal, Nonmetal HIB
    System, Irrigation, Urological LJH
    Accessories, Catheter KGZ
    Nebulizer (Direct Patient Interface) CAF
    Container, Specimen, Sterile FMH
    Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
    Bath, Sitz, Nonpowered KTC
    Container, Liquid Medication, Graduated KYW
    Kit, Surgical Instrument, Disposable KDD
    Catheter, Ureteral, Gastro-Urology EYB
    Shield, Nipple HFS
    Catheters, Suction, Tracheobronchial BSY
    Catheter Care Tray OHR
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Retention Type, Balloon EZL
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Douche Apparatus, Vaginal, Therapeutic HED
    Tube, Aspirating, Flexible, Connecting BYY
    Appliance, Colostomy, Disposable EZS
    Forceps HTD
    Mask, Oxygen, Non-Rebreathing KGB
    Tracheobronchial Suction Catheter Kit OFR
    Trap, Sterile Specimen BYZ
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI
    Pump, Infusion, Enteral LZH
    Catheter And Tip, Suction JOL
    Enteral Syringes With Enteral Specific Connectors PNR
    Suture Removal Kit MCZ
    Saline, Vascular Access Flush NGT
    Mask, Oxygen BYG
    General Surgery Tray LRO
    Tray, Surgical LRP
    Basin, Emesis FNY
    Container, Specimen, Non-Sterile NNI
    Device, Occlusion, Umbilical FOD
    Enteral Administration Kit (Adult & Pediatric) PRM
    I.V. Start Kit LRS
    Irrigation Kit (Wounds) PXY
    Cannula, Nasal, Oxygen CAT
    Syringe, Irrigating (Non Dental) KYZ
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Connector, Catheter GCD
    Tubing, Pressure And Accessories BYX
    Foley Catheter Kit (Excludes Hiv Testing) PPB

    Proprietary Names

    AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush AMSure Enema bucket set AMSure Enema bag set AMSure PVC Catheter AMSure PVC Intermittent Catheter AMSafe NeuFlo Needleless Connector AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE AMSure ENTERAL DELIVERY PUMP SET WITH SPIKE AMSure Enteral Feeding Set AMSure Enteral Delivery Gravity Set Amsafe IV Administration Set Amsino IV Administration Set AMSINO IV Extension Set AMSafe IV Extension Set AMSure IV Extension Set AMSure IV Administration Set AMSure Vaginal Speculum AMSINO Vaginal Speculum AMSure Cystoscopy & TUR Irrigation Sets AMSure Urine Specimen Container AMSure Specimen Container IV Extension Set IV Administration Set AMSafe-3 IV Set AMSure Urinemeter AMSure Sitz Bath Bag AMSure Shave Prep Kit AMSure Convenience Kit AMSure Red Rubber Catheter Amsino Suction Catheter kit AMSure Suction Connecting Tube Amsino Suction Connecting Tube Ostomy Arch Amsino Forceps AMSure Non-rebreather Oxygen Mask AMSure Mucus Trap AMSure Coiled Suction Catheter AMSure Suction Catheter Kit AMSure Suction Catheter AMSure Suture Removal Kit AMSure Suture Removal Tray AMSure Urethral Catheterization Tray AMSafe® Pre-Filled Normal Saline Flush Syringe AMSure Oxygen Mask AMSure Aerosol Mask AMSINO TRACHEOSTOMY CARE TRAY AMSure TRACHEOSTOMY CARE TRAY Amsino Surgical Tray AMSure Foley Insertion Tray AMSure Catheterization Tray AMSafe®Sure-LokTMNeedle-Free Connector Amsino Umbilical Cord Clamp AMSURE NEBULIZER Amisno I.V. Start Kit AMSure I.V. Start Kit Enteral Feeding Syringe Irrigation Tray Irrigation Kit Ear/Ulcer Syringe Bulb Irrigation Syringe Enteral Irrigation Kit Irrigation Syringe AMSure Enteral Feeding Syringe AMSure Irrigation Tray AMSure Bulb Irrigation Syringe AMSure Irrigation Syringe AMSure Irrigation Kit AMSure Enteral Irrigation Kit AMSure Pole Syringe AMSure Ear/Ulcer Syringe AMSure Piston Irrigation Tray Calculi Strainer AMSure Extension Tube AMSure Leg Bag 5 in 1 connector SIMS Connector Aerosol Tubing Medline General Surgery Tray

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device