BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    IgE reagent

    Reg #: 3003985394 · FEI: 3003985394 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SHIMA LABORATORIES CO., LTD.
    Registration Number
    3003985394
    FEI Number
    3003985394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-36-3, MAENO-CHO
    City
    ITABASHI-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K042241

    Owner / Operator

    Firm Name
    SHIMA LABORATORIES CO., LTD.
    Operator Number
    9055348
    Address
    3-36-3 MAENO-CHO ITABASHI-KU, --
    City
    TOKYO
    State
    JP-13
    Postal Code
    --
    Country
    JP
    Correspondent
    AKIKO - HARADA

    US Agent

    Business Name
    KAMIYA BIOMEDICAL COMPANY
    Contact Name
    COLIN GETTY
    Address
    12779 Gateway Drive S, Tukwila, WA
    City
    Seattle
    State
    WA
    ZIP
    98168
    Country
    US
    Email
    [email protected]
    Phone
    206 5758068

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Ige, Antigen, Antiserum, Control DGC

    Proprietary Names

    IgE reagent

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device