BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PLAYTEX MANUFACTURING INC.

    Reg #: 2515444 · FEI: 2515444 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    69
    Establishment Types
    4
    Classifications
    5

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    Registration Details

    Registration Name
    PLAYTEX MANUFACTURING INC.
    Registration Number
    2515444
    FEI Number
    2515444
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    804 Walker Rd
    City
    DOVER
    State
    DE
    ZIP
    19904
    Country
    US

    Regulatory Submissions

    510(k) Number
    K990536

    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

    Products

    Device Name Product Code
    Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile NRC
    Tampon, Menstrual, Unscented HEB
    Pad, Menstrual, Unscented HHD
    Tampon, Menstrual, Scented, Scented-Deodorized HIL
    Garment, Protective, For Incontinence EYQ

    Proprietary Names

    CAREFREE® Original Liners CAREFREE® Acti-fresh Liners STAYFREE® Ultra Thin Pads STAYFREE® Maxi Pads Saba Menstrual Pads, Scented o.b. Original Tampons - applicator and non-applicator versions Playtex Stella Saba Menstrual Pad Unscented CAREFREE® Breathe™ Ultra Thin Pads Playtex® Sport™ Liners Playtex® Gentle Glide (Unscented) Tampons Playtex® Gentle Glide (Unscented) Multipack Tampons Playtex® Gentle Glide Plastic (Scented) Tampons Playtex® Gentle Glide Plastic (Unscented) Tampons Playtex® Gentle Glide Plastic (Scented) Multipack Tampons Playtex® Gentle Glide Plastic (Unscented) Multipack Tampons Playtex® Non-deodorant and Deodorant Slimfits® Playtex® Nondeodorant and Deodorant Gentle Glide® Multipack Tampons Playtex® Non-deodorant and Deodorant Portables Playtex® Non-deodorant, Deodorant and Odor-absorbing Gentle Glide® 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 Playtex® Gentle Glide (Scented) Tampons Playtex® Simply Gentle Glide (Unscented) Tampons Playtex® Simply Gentle Glide (Scented) Tampons Playtex® Clean Comfort Tampons Playtex® Sport Plastic Tampons, Fresh Scent Playtex® Sport Plastic, Unscented Playtex® Deodorant Tampons (Model 34802) Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons Playtex® Sport (Scented) Tampons with Odorshield Playtex® Sport (Unscented) Tampons with Odorshield Playtex® (Scented) Sport Fresh Balance Tampon Playtex® Sport Compact (unscented) Tampons Playtex® (Unscented) Sport Fresh Balance Tampons o.b. ProComfort Tampons Playtex® Gentle Glide and Playtex® Multipack Tampons

    Establishment Types

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