BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Thermo Scientific Forma Incubator, Direct Heat, ivf (360)

    Reg #: 1523845 · FEI: 1523845 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
    Registration Number
    1523845
    FEI Number
    1523845
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    401 MILLCREEK RD.
    City
    MARIETTA
    State
    OH
    ZIP
    45750
    Country
    US

    Regulatory Submissions

    510(k) Number
    K001524

    Owner / Operator

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

    Products

    Device Name Product Code
    Accessory, Assisted Reproduction MQG

    Proprietary Names

    Thermo Scientific Forma Incubator, Direct Heat, ivf (360) Thermo Scientific Forma Incubator, Direct Heat, ivf (361) Thermo Scientific Forma Incubator, Direct Heat, ivf (310) Thermo Scientific Forma Incubator, Direct Heat, ivf (311) Thermo Scientific Forma Incubator, Direct Heat, ivf (321) Thermo Scientific Forma Incubator, Direct Heat, ivf (351) Thermo Scientific Forma Incubator, Direct Heat, ivf (320) Thermo Scientific Forma Incubator, Direct Heat, ivf (350)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device