BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LITHOCLAST MASTER HANDPIECE & 3.2MM PROBE

    Reg #: 1648564 · FEI: 3000205943 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ELECTRO MEDICAL SYSTEMS, L.L.C.
    Registration Number
    1648564
    FEI Number
    3000205943
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2150E Continental Boulevard
    City
    Southlake
    State
    TX
    ZIP
    76092
    Country
    US

    Regulatory Submissions

    510(k) Number
    K974164

    Owner / Operator

    Firm Name
    ELECTRO MEDICAL SYSTEMS, INC.
    Operator Number
    9025157
    Address
    2150 E Continental Blvd
    City
    Southlake
    State
    TX
    Postal Code
    76092
    Country
    US
    Correspondent
    Jean-Baptiste AMADIEU

    Products

    Device Name Product Code
    Lithotriptor, Electro-Hydraulic FFK

    Proprietary Names

    LITHOCLAST MASTER HANDPIECE & 3.2MM PROBE

    Establishment Types

    Remanufacture Medical Device Repack or Relabel Medical Device