BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Test band

    Reg #: 3007367732 · FEI: 3007367732 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Oticon Medical AB
    Registration Number
    3007367732
    FEI Number
    3007367732
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Datavagen 37B
    City
    Askim Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K082108

    Owner / Operator

    Firm Name
    DEMANT A/S
    Operator Number
    8010048
    Address
    KONGEBAKKEN 9, --
    City
    SMORUM
    State
    DK-NOTA
    Postal Code
    DK-2765
    Country
    DK

    US Agent

    Business Name
    OTICON MEDICAL, LLC
    Contact Name
    Laura Dixon
    Address
    580 Howard Ave, Somerset
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    760 9082393 ext. 181

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB

    Proprietary Names

    Test band Cover screw hexagon Soft band, bilateral, Red Soft band, bilateral, Pink Soft band, bilateral, Beige Sound processor indicator Soft band, Red Soft band, bilateral, Light blue Soft band, Pink Guide drill, 3 - 4 mm Soft band, Navy blue Screwdriver, machine Head band Healing cap Soft band, Beige Handle with screwdriver Soft band, bilateral, Navy blue Soft band, Light blue Abutment inserter, machine Square fit connection, machine Soft band, Black Counter torque wrench Screwdriver hexagon Soft band, bilateral, Black

    Establishment Types

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