BEUDAMED
    FDA Registration Active 🇨🇳 China

    LDE4 AST

    Reg #: 3014649053 · FEI: 3014649053 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Sterilance Medical (Suzhou) Inc.
    Registration Number
    3014649053
    FEI Number
    3014649053
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.168 PuTuoShan Road, New District
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221970

    Owner / Operator

    Firm Name
    Sterilance Medical (Suzhou) Inc.
    Operator Number
    9070037
    Address
    No.168 PuTuoShan Road, New District
    City
    SUZHOU
    State
    Jiangsu
    Postal Code
    215133
    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
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    LDE4 AST OneStep LDE AST LDE4 SteriLance Lancing Device LDE 4-AST NanoSense LDE

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device