BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    MYOCENE

    Reg #: 3036833452 · FEI: 3036833452 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MYOCENE
    Registration Number
    3036833452
    FEI Number
    3036833452
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Quai Banning 6
    City
    Liege
    Country
    BE

    Regulatory Submissions

    510(k) Number
    DEN230051

    Owner / Operator

    Firm Name
    Myocene
    Operator Number
    10092733
    Address
    Quai Banning 6
    City
    Liège
    State
    Liege
    Postal Code
    4000
    Country
    BE
    Correspondent
    Jean-Yves Mignolet

    US Agent

    Business Name
    Myocene US Inc
    Contact Name
    Jean-Yves Mignolet
    Address
    16192 Coastal Hwy
    City
    Lewes
    State
    DE
    ZIP
    19958
    Country
    US
    Email
    [email protected]
    Phone
    800 4109718

    Products

    Device Name Product Code
    Neuromuscular Stimulator And Exercise Evaluation System SDX

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device