BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Unyvero L4 Lysator

    Reg #: 3011586215 · FEI: 3011586215 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Zollner Elektronik AG, Plant Zandt 2
    Registration Number
    3011586215
    FEI Number
    3011586215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Wiesenweg 1
    City
    Zandt Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    DEN170047

    Owner / Operator

    Firm Name
    Zollner Elektronik AG
    Operator Number
    10055673
    Address
    Manfred-Zollner-Str. 1
    City
    Zandt
    State
    Bavaria
    Postal Code
    93499
    Country
    DE
    Correspondent
    Harald Reichhardt

    US Agent

    Business Name
    Zollner Electronics Inc
    Contact Name
    Azfar Jafri
    Address
    575 Cottonwood Drive, Zollner Electronics Inc. Plant Milpitas
    City
    Milpitas
    State
    CA
    ZIP
    95035
    Country
    US
    Email
    [email protected]
    Phone
    408 3829828

    Products

    Device Name Product Code
    Lower Respiratory Microbial Nucleic Acid Detection System QBH

    Proprietary Names

    Unyvero L4 Lysator Unyvero C8 Cockpit Unyvero A50 Analyzer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)