BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Lithovac lv3 Set

    Reg #: 8030987 · FEI: 3002806910 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
    Registration Number
    8030987
    FEI Number
    3002806910
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    31 CH. DE LA VUARPILLIERE
    City
    NYON Vaud
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K964111

    Owner / Operator

    Firm Name
    E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
    Operator Number
    9057430
    Address
    31 CH. DE LA VUARPILLIERE, --
    City
    NYON, VAUD
    State
    CH-NOTA
    Postal Code
    CH-1260
    Country
    CH
    Correspondent
    S. - FASSIO-HARDY

    US Agent

    Business Name
    ELECTRO MEDICAL SYSTEMS, L.L.C.
    Contact Name
    JEAN BAPTISTE AMADIEU
    Address
    2150 E Continental Blvd
    City
    Southlake
    State
    TX
    ZIP
    76092
    Country
    US
    Email
    [email protected]
    Phone
    972 6908382 ext. 104

    Products

    Device Name Product Code
    Lithotriptor, Electro-Hydraulic FFK
    Evacuator, Gastro-Urology KQT

    Proprietary Names

    Lithovac lv3 Set

    Establishment Types

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