BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    MOR System

    Reg #: 3016908271 · FEI: 3016908271 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Nextern Vietnam LLC
    Registration Number
    3016908271
    FEI Number
    3016908271
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    C1B-5D, Lot C-1B-CN, DE5 Road, My Phuoc 3 IP
    City
    Ben Cat District Binh Duong
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K241897

    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
    Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation QRC

    Proprietary Names

    MOR System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)