BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    VENTANA® DP 600 slide scanner

    Reg #: 3005060446 · FEI: 3005060446 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARL ZEISS CMP GMBH
    Registration Number
    3005060446
    FEI Number
    3005060446
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Koenigsallee 9-21
    City
    Goettingen Lower Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K242783

    Owner / Operator

    Firm Name
    Carl Zeiss CMP GmbH
    Operator Number
    10091355
    Address
    Koenigsallee 9-21
    City
    Göttingen
    State
    Lower Saxony
    Postal Code
    37081
    Country
    DE
    Correspondent
    Johannes Pfingstmann

    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
    Whole Slide Imaging System PSY

    Proprietary Names

    VENTANA® DP 600 slide scanner

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)