BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Laerdal Face Shield

    Reg #: 3013484413 · FEI: 3013484413 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPECIALPLAST WENSBO AB
    Registration Number
    3013484413
    FEI Number
    3013484413
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Baldersvaegen
    City
    Gislaved Jonkoping
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K880450

    Owner / Operator

    Firm Name
    Specialplast Wensbo AB
    Operator Number
    10090990
    Address
    Baldersvaegen
    City
    Gislaved
    State
    Jonkoping
    Postal Code
    33222
    Country
    SE
    Correspondent
    Roger Grundstroem

    US Agent

    Business Name
    Target Health
    Contact Name
    Mittal Suthar
    Address
    450 Commerce Blvd
    City
    Carlstadt
    State
    NJ
    ZIP
    07072
    Country
    US
    Email
    [email protected]
    Phone
    212 6812100

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    Laerdal Face Shield

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)