BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    IotaSOFT Insertion System

    Reg #: 3023531666 · FEI: 3023531666 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Nextern Costa Rica Ltd.
    Registration Number
    3023531666
    FEI Number
    3023531666
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Multitenant 2 Modulo 4.
    City
    Cartago
    Country
    CR

    Regulatory Submissions

    510(k) Number
    DEN190055

    Owner / Operator

    Firm Name
    Nextern Innovation, Inc
    Operator Number
    10037078
    Address
    10601 Fountains Drive
    City
    Maple Grove
    State
    MN
    Postal Code
    55369
    Country
    US
    Correspondent
    Caroline Byrd

    US Agent

    Business Name
    NEXTERN INNOVATION, INC
    Contact Name
    Caroline Byrd
    Address
    10601 Fountains Drive
    City
    Maple Grove
    State
    MN
    ZIP
    55369
    Country
    US
    Email
    [email protected]
    Phone
    651 2032100

    Products

    Device Name Product Code
    Powered Insertion System For A Cochlear Implant Electrode Array QQH

    Proprietary Names

    IotaSOFT Insertion System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)