BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Molnlycke Health Care SDN BHD

    Reg #: 3025355668 · FEI: 3025355668 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Molnlycke Health Care SDN BHD
    Registration Number
    3025355668
    FEI Number
    3025355668
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lot 12A, Jalan Hi-Tech 7, Industrial Zone Phase 2, Kulim Hi-Tech Park
    City
    Kulim Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K053443

    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
    Yannick Spenninck

    US Agent

    Business Name
    MOLNLYCKE HEALTH CARE US LLC
    Contact Name
    Yannick Spenninck
    Address
    5445 Triangle Parkway, Suite 400
    City
    Peachtree Corners
    State
    GA
    ZIP
    30092
    Country
    US
    Email
    [email protected]
    Phone
    470 3903565

    Products

    Device Name Product Code
    Surgeon'S Gloves KGO

    Proprietary Names

    Biogel Eclipse Biogel Skinsense N Biogel NeoDerm Biogel Skinsense Indicator Underglove BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Biogel Super-Sensitive surgical glove Biogel Sensor Glove Biogel Opti-Fit Ortho surgical gloves Biogel PI OrthoPro Biogel Skinsense Biogel PI surgical glove Biogel PI Pro-Fit surgical glove Biogel PI UltraTouch M surgical glove Biogel PI Ultratouch G surgical glove Biogel PI UltraTouch surgical glove Biogel PI UltraTouch S Indicator Underglove Biogel PI UltraTouch S Surgical Glove Biogel Indicator Underglove Biogel PI Indicator

    Establishment Types

    Manufacture Medical Device