BEUDAMED
    FDA Registration Active 🇨🇳 China

    Mckesson Pen Needles

    Reg #: 3015955792 · FEI: 3015955792 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SANDSTONE MEDICAL (SUZHOU) INC.
    Registration Number
    3015955792
    FEI Number
    3015955792
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 6, No.168 PuTuoShan Road, New District
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K193422

    Owner / Operator

    Firm Name
    Sandstone Medical (Suzhou) INC.
    Operator Number
    10080666
    Address
    Building 6, No.168 PuTuoShan Road, New District
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215153
    Country
    CN

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Mckesson Pen Needles Pen Needle Easydrip Easydrip Plus Pen needle 32Gx6mm Embrace® Pen Needles Pen needle 30Gx5mm GLUCO-CARE PLUS Pen Needle ONE-CARE Pen Needle Sitesmart Pen Needles GLUCO-CARE Classic Pen Needle SOL.M Pen Needles

    Establishment Types

    Manufacture Medical Device