BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant

    Reg #: 3014766734 · FEI: 3014766734 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant
    Registration Number
    3014766734
    FEI Number
    3014766734
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-23 Tsukinoiri, Kayane
    City
    Shirakawa Fukushima
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K120781

    Owner / Operator

    Firm Name
    FUJI SYSTEMS CORPORATION
    Operator Number
    9052600
    Address
    23-14, HONGO 3-CHOME, BUNKYO-KU, --
    City
    TOKYO
    State
    JP-13
    Postal Code
    113-0033
    Country
    JP

    Products

    Device Name Product Code
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Enteroscope And Accessories FDA
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Catheter, Percutaneous DQY
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Tube, Tracheal (W/Wo Connector) BTR
    Catheter, Retention Type, Balloon EZL
    Catheter, Percutaneous, Neurovasculature QJP

    Proprietary Names

    CELLO Balloon Guide Catheter; 6F, 7F, 8F, 9F Wire Reinforced Endotracheal Tube Univent Tube 7mm, 7.5mm, 8mm, 8.5mm, 9mm Silbroncho Double Lumen Tube Pediatric Cuffed And Uncuffed Et Tube; Standard Cuffed and Uncuffed Et Tube Phycon All Silicone Balloon Catheter

    Establishment Types

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