BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    MEDISPEC, LTD.

    Reg #: 3002807616 · FEI: 3002807616 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    MEDISPEC, LTD.
    Registration Number
    3002807616
    FEI Number
    3002807616
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    40 HATAASIYA ST.
    City
    YEHUD Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K040461
    PMA Number
    P950043

    Owner / Operator

    Firm Name
    MEDISPEC, LTD.
    Operator Number
    9006433
    Address
    203 Perry Parkway, SUITE 6
    City
    Gaithersburg
    State
    MD
    Postal Code
    20877
    Country
    US

    US Agent

    Business Name
    MEDISPEC, LTD.
    Contact Name
    Avner Spector
    Address
    203 Perry Pkwy Ste 6
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5527310

    Products

    Device Name Product Code
    Lithotriptor, Extracorporeal Shock-Wave, Urological LNS
    Device, Digital Image Storage, Radiological LMB
    Massager, Therapeutic, Electric ISA
    Uroflowmeter EXY
    Table, Operating-Room, Ac-Powered FQO
    Lithotriptor, Electro-Hydraulic FFK
    Generator, Shock-Wave, For Pain Relief NBN

    Proprietary Names

    Econolith E3000 Econolith EM1000 ECONOLITH Model 2000 Lithotripter System Omnispec™ ED1000 Alma Duo Urospec Endo Comfort Lithospec SlimSpec Nephrospec Vascuspec RADIALSPEC Cardiospec Omnispec Model Orthospec Radialspec Neo Orthospec

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)