BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Ponto bone anchored hearing system

    Reg #: 3005216725 · FEI: 3005216725 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CENOVA AB
    Registration Number
    3005216725
    FEI Number
    3005216725
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4, FLORETTGATAN
    City
    MJOLBY Ostergotland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K121228

    Owner / Operator

    Firm Name
    CENOVA AB
    Operator Number
    9043892
    Address
    4, FLORETTGATAN, --
    City
    MJOLBY
    State
    SE-NOTA
    Postal Code
    595 43
    Country
    SE
    Correspondent
    Jeanette - Erbay

    US Agent

    Business Name
    Obelix Consulting
    Contact Name
    Elisa Maldonado-Holmertz
    Address
    806 Jefferson St
    City
    Bastrop
    State
    TX
    ZIP
    78602
    Country
    US
    Email
    [email protected]
    Phone
    512 4316069

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction, Implanted MAH

    Proprietary Names

    Ponto bone anchored hearing system

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)