BEUDAMED
    FDA Registration Active 🇨🇳 China

    ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD

    Reg #: 3008797804 · FEI: 3008797804 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    18

    Registration Details

    Registration Name
    ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD
    Registration Number
    3008797804
    FEI Number
    3008797804
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.24 Building Jinshao Rd.1688.Baoshan District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242635

    Owner / Operator

    Firm Name
    ALTON shanghai medical Instruments Co Ltd
    Operator Number
    10034985
    Address
    No.24 Building, Jinshao Rd.1688, Baoshan District.
    City
    Shanghai
    State
    CN-SH
    Postal Code
    200949
    Country
    CN
    Correspondent
    Haoxiang HE

    US Agent

    Business Name
    XENTURA MEDICAL, INC.
    Contact Name
    Brian Karler Brian Karler
    Address
    4709 E La Mirada Way
    City
    Phoenix
    State
    AZ
    ZIP
    85044
    Country
    US
    Email
    [email protected]
    Phone
    480 7976714

    Products

    Device Name Product Code
    Gastroscope And Accessories, Flexible/Rigid FDS
    Colonoscope And Accessories, Flexible/Rigid FDF
    Endoscopic Bite Block MNK
    Endoscopic Cytology Brush FDX
    Bronchoscope Accessory KTI
    Ligator, Hemorrhoidal FHN
    Bottle, Collection, Vacuum KDQ
    Stent, Ureteral FAD
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Biliary Catheter For Irrigation And Contrast Injection, Exempt PTT
    Ligator, Esophageal MND
    Endoscope Channel Accessory ODC
    Device, Measuring, For Panendoscope FDY
    Accessories, Cleaning Brushes, For Endoscope MNL
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Attachment, Teaching, For Endoscope FEA
    Hemostatic Metal Clip For The Gi Tract PKL

    Proprietary Names

    Bite Blocks Disposable Cytology Brush (AF series) Disposable hemorrhoid ligation Ligation device Disposable Drainage Collection device Disposable Injection Needle Biliary Plastic Stent Multi-Band Ligator Disposable measuring Ruler Disposable Cleaning Brush Port Hole Cleaning Brush Reusable Cleaning Brush Disposable Guidewire Disposable Grasping Forceps Reusable Grasping Forceps Retrieval Basket Polyp Trap Valve Cap Disposable Hemoclip

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device