BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Phadia 1000

    Reg #: 3031570369 · FEI: 3031570369 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HITACHI HIGH-TECH CORP., Musashimurayama Center
    Registration Number
    3031570369
    FEI Number
    3031570369
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-26-37 Inadaira
    City
    Musashimurayama Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K051218

    Owner / Operator

    Firm Name
    HITACHI HIGH-TECH CORP.
    Operator Number
    9049564
    Address
    1-17-1 Toranomon,, --
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    105-6409
    Country
    JP

    Products

    Device Name Product Code
    System, Test, Radioallergosorbent (Rast) Immunological DHB

    Proprietary Names

    Phadia 1000 Phadia 2500 Phadia 5000 Phadia 250

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)