BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    MYOCENE

    Reg #: 3036833452 · FEI: 3036833452 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    MYOCENE
    Registration Number
    3036833452
    FEI Number
    3036833452
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Quai Banning 6
    City
    Liege
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K132998

    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
    Techlink International LLC
    Contact Name
    Lilian Llull
    Address
    2875 Ne 191st St # 539
    City
    Aventura
    State
    FL
    ZIP
    33180
    Country
    US
    Email
    [email protected]
    Phone
    305 2066777

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY
    Neuromuscular Stimulator And Exercise Evaluation System SDX

    Proprietary Names

    Myocene Electrode 1

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198