BEUDAMED
    FDA Registration Active 🇨🇳 China

    Press2

    Reg #: 3014649053 · FEI: 3014649053 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    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
    K221521

    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
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    Press2 Press2 Plus Lite3 Press Plus Press Safety Pressure Activated Lancets Embrace® Pressure Activated Safety Lancets Flex3 UltraLANCE™ Sterile Safety Lancets

    Establishment Types

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