BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Ponto 3 SuperPower Demo, L, CBE

    Reg #: 3009307953 · FEI: 3009307953 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    73
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Demant Operations Poland Sp. z o.o.
    Registration Number
    3009307953
    FEI Number
    3009307953
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ul. Lubieszynska 59
    City
    Mierzyn Zachodniopomorskie
    Country
    PL

    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
    Correspondent
    Veronique Schou

    US Agent

    Business Name
    Oticon Inc.
    Contact Name
    Love Aggarwal
    Address
    580 Howard Ave
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    732 8534740

    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

    Manufacture Medical Device for Another Party (Contract Manufacturer)