BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Biogel PI surgical glove

    Reg #: 9610054 · FEI: 1000207790 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Molnlycke Health Care SDN BHD
    Registration Number
    9610054
    FEI Number
    1000207790
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 9, LORONG PERUSAHAAN 4, KULIM INDUSTRIAL ESTATE
    City
    KULIM Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K053442

    Owner / Operator

    Firm Name
    MOLNLYCKE HEALTH CARE US LLC
    Operator Number
    8030877
    Address
    5445 Triangle Parkway, Suite 400
    City
    Peachtree Corners
    State
    GA
    Postal Code
    30092
    Country
    US
    Correspondent
    Megan Bevill

    US Agent

    Business Name
    Molnlycke Health Care
    Contact Name
    Megan Bevill
    Address
    5445 Triangle Parkway, Suite 400
    City
    Peachtree Corners
    State
    GA
    ZIP
    30092
    Country
    US
    Email
    [email protected]
    Phone
    770 5479196

    Products

    Device Name Product Code
    Surgeon'S Gloves KGO

    Proprietary Names

    Biogel PI surgical glove

    Establishment Types

    Manufacture Medical Device