BEUDAMED
    FDA Registration Active 🇸🇰 Slovakia

    UI400

    Reg #: 3024021261 · FEI: 3024021261 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MDTGLOBAL, A.S.
    Registration Number
    3024021261
    FEI Number
    3024021261
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lomonosovova 2
    City
    Bratislava Bratislavsky
    Country
    SK

    Regulatory Submissions

    510(k) Number
    K161554

    Owner / Operator

    Firm Name
    MDTGlobal, a.s.
    Operator Number
    10085911
    Address
    Lomonosovova 2
    City
    Bratislava
    State
    Bratislavsky
    Postal Code
    811 09
    Country
    SK
    Correspondent
    Richard Cunderlik

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Insufflator, Laparoscopic HIF
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Insufflator, Endoscopic Vessel Harvesting OSV

    Proprietary Names

    UI400

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device