BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vit Kit - Warm NX

    Reg #: 2022379 · FEI: 2022379 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FUJIFILM IRVINE SCIENTIFIC, INC.
    Registration Number
    2022379
    FEI Number
    2022379
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2511 DAIMLER ST
    City
    Santa Ana
    State
    CA
    ZIP
    92705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190152

    Owner / Operator

    Firm Name
    FUJIFILM Holdings America Corporation
    Operator Number
    2022379
    Address
    2511 DAIMLER STREET, --
    City
    Santa Ana
    State
    CA
    Postal Code
    92705
    Country
    US
    Correspondent
    Marlin Frechette

    Products

    Device Name Product Code
    Media, Reproductive MQL

    Proprietary Names

    Vit Kit - Warm NX Vit Kit - Freeze NX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)