BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Molnlycke Health Care AB

    Reg #: 3007048057 · FEI: 3007048057 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    85
    Establishment Types
    3
    Classifications
    20

    Registration Details

    Registration Name
    Molnlycke Health Care AB
    Registration Number
    3007048057
    FEI Number
    3007048057
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Entreprenorsstraket 21
    City
    Molndal Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K130040

    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
    Dressing, Wound, Occlusive NAD
    Dressing, Wound, Drug FRO
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Surgeon'S Gloves KGO
    Latex Patient Examination Glove LYY
    Dressing, Wound, Hydrophilic NAC
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
    Mask, Surgical FXX
    Respirator, Surgical MSH
    Radiation Attenuating Medical Glove OPH
    Bandage, Elastic FQM
    Cap, Surgical FYF
    Mattress, Flotation Therapy, Non-Powered IKY
    Device, Transfer, Patient, Manual FMR
    Elastomer, Silicone, For Scar Management MDA
    Tape And Bandage, Adhesive KGX
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Protector, Skin Pressure FMP
    Lift, Patient, Ac-Powered FNG
    Lift, Patient, Non-Ac-Powered FSA

    Proprietary Names

    MEFILM MEPITEL ONE Mepitel Film MEPITEL Mepore Film Mepitel Ag Biogel Skinsense N Biogel NeoDerm Biogel Skinsense Indicator Underglove Biogel PI OrthoPro Biogel PI Indicator Biogel M Exufiber Ag+ Biogel Surgeons Glove Biogel Diagnostic Biogel PI Pro-Fit surgical glove Biogel PI UltraTouch M surgical glove Biogel PI Ultratouch G surgical glove Biogel PI UltraTouch surgical glove 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 Biogel PI Micro Indicator Underglove Mepilex Border Heel Ag Mepilex Border Sacrum Ag Mepilex Border Post Op Ag Mepilex Border Ag Normlgel face Mask Barrier Medical Face Mask Barrier N95 Particulate Respirator Biogel Opti-Fit Ortho surgical gloves Biogel PI Micro surgical glove Dermafit Tubipad Tubigrip Setopress Tubifast Elset Barrier Surgical Cap Barrier Nurse's Cap Barrier Surgical Hood Molnlycke Static Air BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Biogel PI UltraTouch S Indicator Underglove Biogel PI UltraTouch S Surgical Glove Tortoise Turning and Positioning System Mepiform Biogel PI surgical glove Biogel Skinsense Biogel Indicator Underglove Mepitac Mefix Multiple wound dressings Avance Solo NPWT System Biogel Eclipse Mepilex Transfer Ag Mepilex Ag Static Air Heel Protector Z-Flex Heel Boot Z-Flo Fluidized Positioner Biogel Super-Sensitive surgical glove Biogel Sensor Glove

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198