BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Spectra (Micrusfram, Deltafill, Deltaxsft, Galaxy G3, Galaxy G3 XSFT, Galaxy G3 mini) Microcoil Delivery System

    Reg #: 3008114965 · FEI: 3008114965 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDOS INTERNATIONAL SARL
    Registration Number
    3008114965
    FEI Number
    3008114965
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Chemin-Blanc 38
    City
    Le Locle Neuchatel
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K211344

    Owner / Operator

    Firm Name
    Medos International SARL
    Operator Number
    10031083
    Address
    4600 Riverside Drive
    City
    Palm Beach Gardens
    State
    FL
    Postal Code
    33410
    Country
    US
    Correspondent
    Karen Parker

    Products

    Device Name Product Code
    Device, Vascular, For Promoting Embolization KRD
    Device, Neurovascular Embolization HCG

    Proprietary Names

    Spectra (Micrusfram, Deltafill, Deltaxsft, Galaxy G3, Galaxy G3 XSFT, Galaxy G3 mini) Microcoil Delivery System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility