BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Ponto 3 SuperPower Demo, L, CBE

    Reg #: 3007367732 · FEI: 3007367732 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    73
    Establishment Types
    2
    Classifications
    3

    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
    K161671

    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, Air-Conduction, Prescription ESD
    Hearing Aid, Bone Conduction, Implanted MAH
    Hearing Aid, Bone Conduction LXB

    Proprietary Names

    Ponto 3 SuperPower Demo, L, CBE Ponto Soft band, bilateral, brown Ponto 3, L, PUW Ponto 3 Power, L, PUW Ponto 3, L, STG Ponto SoundConnector Ponto 3 Demo, R, CBE Ponto Soft band, brown Ponto 3 SuperPower Demo, R, CBE Ponto Soft band, bilateral, black Ponto 3, R, MBR Ponto Soft band, red Demo BL Oticon Medical Streamer Ponto Soft band, grey Ponto 3 SuperPower, L, WHS Ponto Soft band, navy Ponto Soft band, bilateral, navy WH Oticon Medical Streamer Ponto Soft band, turquoise Ponto 3, L, WHS Ponto 3, R, DBL Ponto 3 Power, R, DBL Ponto 3 Power, R, WHS Ponto 3 SuperPower, R, STG Ponto Soft band, bilateral, turquoise Ponto Soft band, beige Ponto 3 Power, L, STG Ponto 3 SuperPower, L, PUW Ponto Soft band, bilateral, green Ponto 3, L, CBE Ponto 3, R, CBE Ponto 3 Power, L, CBE Ponto 3, L, DBL Ponto 3 Power, L, DBL Ponto 3 SuperPower, L, CBE Ponto Soft band, cerise Ponto Soft band, bilateral, cerise Ponto 3, R, STG Ponto 3 Power, R, STG Ponto Soft band, yellow Ponto 3 Demo, L, CBE Ponto 3 SuperPower, L, DBL Ponto Soft band, bilateral, beige Ponto 3 SuperPower, R, PUW Ponto Soft band, bilateral, grey Ponto 3 SuperPower, R, MBR Ponto Soft band, pink Ponto Soft band, bilateral, pink Ponto 3, R, PUW Ponto 3 Power, R, PUW Ponto Soft band, black Ponto 3 SuperPower, L, MBR Ponto Soft band, bilateral, red Ponto 3, R, WHS Genie Medical Ponto Soft band, blue Ponto Soft band, bilateral, blue Ponto 3 Power, L, WHS Ponto 3 SuperPower, L, STG Ponto 3 SuperPower, R, CBE Ponto Soft band, purple Ponto Soft band, bilateral, purple BL Oticon Medical Streamer Ponto Soft band, green Ponto 3, L, MBR Ponto 3 Power, L, MBR Ponto 3 Power, R, MBR Ponto 3 SuperPower, R, DBL Ponto Soft band, bilateral, yellow Ponto 3 Power, R, CBE Ponto 3 SuperPower, R, WHS Ponto Soft band, indigo Ponto Soft band, bilateral, indigo

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device