BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Thermo Scientific Heracell 150i Incubator

    Reg #: 9617472 · FEI: 3005737891 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    THERMO ELECTRON LED GmbH
    Registration Number
    9617472
    FEI Number
    3005737891
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Robert-Bosch-Strasse1
    City
    Langenselbold Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K023465

    Owner / Operator

    Firm Name
    THERMO FISHER SCIENTIFIC INC.
    Operator Number
    2182773
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    US Agent

    Business Name
    THERMO FISHER SCIENTIFIC
    Contact Name
    MARILYN BARRY
    Address
    275 AIKEN RD.
    City
    ASHEVILLE
    State
    NC
    ZIP
    28804
    Country
    US
    Email
    [email protected]
    Phone
    828 6584400

    Products

    Device Name Product Code
    Accessory, Assisted Reproduction MQG

    Proprietary Names

    Thermo Scientific Heracell 150i Incubator Thermo Scientific Heracell 240i Incubator

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198