BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    Urisys 1100

    Reg #: 1000369487 · FEI: 1000369487 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    77 ELEKTRONIKA KFT.
    Registration Number
    1000369487
    FEI Number
    1000369487
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fehervari ut 98.
    City
    Budapest
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K033548

    Owner / Operator

    Firm Name
    77 Elektronika Kft.
    Operator Number
    10041281
    Address
    Fehervari ut 98.
    City
    Budapest
    State
    HU-BU
    Postal Code
    1116
    Country
    HU
    Correspondent
    Oliver Babinszki

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Automated Urinalysis System KQO
    Reagent, Occult Blood KHE

    Proprietary Names

    Urisys 1100

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)