BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Essity Hygiene and Health AB

    Reg #: 8030877 · FEI: 3005155428 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    39
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Essity Hygiene and Health AB
    Registration Number
    8030877
    FEI Number
    3005155428
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Molndal Bro 2
    City
    Gothenburg Vastra Gotaland
    Country
    SE

    Owner / Operator

    Firm Name
    Essity Hygiene and Health AB
    Operator Number
    9040833
    Address
    Molndal Bro 2
    City
    Gothenburg
    State
    Vastra Gotaland
    Postal Code
    SE-405 03
    Country
    SE

    US Agent

    Business Name
    ESSITY HMS NORTH AMERICA INC.
    Contact Name
    Sean Anderson
    Address
    5825 Carnegie Blvd
    City
    Charlotte
    State
    NC
    ZIP
    28209
    Country
    US
    Email
    [email protected]
    Phone
    959 5997401

    Products

    Device Name Product Code
    Pad, Menstrual, Reusable NUQ
    Alarm, Conditioned Response Enuresis KPN
    Pad, Menstrual, Scented, Scented-Deodorized HHL
    Cover, Mattress (Medical Purposes) FMW
    Garment, Protective, For Incontinence EYQ

    Proprietary Names

    TENA SmartCare Identifi TENA SmartCare Change Indicator TENA® Air Flow Underpad TENA InstaDri Air™ Underpad TENA® Underpads TENA® Dry Comfort™ Briefs Carefree Serenity lights by TENA TENA Intimates TENA Stylish TENA Comfort / TENA ProSkin™ Fully Breathable Absorbent Pads TENA Stretch / TENA ProSkin™ Stretch Briefs TENA ProSkin™ Stretch Ultra Briefs 2XL TENA Super / TENA ProSkin™ Super Briefs TENA Fixation / TENA ProSkin™ Comfort Pants TENA Men Super Plus TENA® Stretch Plus Briefs 2XL TENA Sensitive Care TENA ProSkin™ Stretch Super Briefs 3XL TENA ProSkin™ Plus Protective Underwear TENA® Stretch Plus Briefs TENA Ultra / TENA ProSkin™ Ultra Briefs TENA ProSkin™ Overnight Super Protective Underwear TENA Dry Comfort® Protective Underwear TENA ProSkin™ Extra Protective Underwear TENA Intimates Overnight TENA Men Shield TENA ProSkin™ Underwear for Women TENA ProSkin™ Flex TENA ProSkin® Plus XS Brief TENA ProSkin™ Underwear for Men TENA® Complete Briefs TENA Sensitive Care Overnight TENA® Classic Protective Underwear TENA Proskin™ TENA Men Guard Stayfree TENA Complete +Care Ultra™ Briefs

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device