BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Molnlycke Health Care Oy

    Reg #: 3007605720 · FEI: 3007605720 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Molnlycke Health Care Oy
    Registration Number
    3007605720
    FEI Number
    3007605720
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Saimaankatu 6 PO Box 76
    City
    Mikkeli Etela-Savo
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K100029

    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
    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
    Tape And Bandage, Adhesive KGX
    Dressing, Wound, Drug FRO
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Dressing, Wound, Occlusive NAD
    Elastomer, Silicone, For Scar Management MDA
    Dressing, Wound, Hydrophilic NAC

    Proprietary Names

    Mepitac Mefix Multiple wound dressings Mepilex Border Heel Ag Mepilex Border Sacrum Ag Mepilex Border Post Op Ag Mepilex Border Ag Avance Solo NPWT System Mepitel Ag Mepilex Ag Exufiber Ag+ MEFILM MEPITEL ONE Mepitel Film MEPITEL Mepore Film Mepilex Transfer Ag Mepiform Mepilex Border Lite Mepilex Mepilex Border Mextra Superabsorbent Mepilex XT Exufiber Mepilex Border Heel Mepilex Transfer Mepore Pro Mepilex Border Flex Mepilex Heel Melgisorb Plus Mepilex Border Post Op Mestopore Mesorb Mepore Film and Pad Mepilex Border Flex Lite Mepilex Up Mestopore S Mepore Roll Mepilex Border Sacrum MESALT MEPORE ALLDRESS Mepilex Lite

    Establishment Types

    Manufacture Medical Device