BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    CITIZEN SYSTEMS JAPAN CO., LTD.

    Reg #: 8031509 · FEI: 3005176386 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    2

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    Registration Details

    Registration Name
    CITIZEN SYSTEMS JAPAN CO., LTD.
    Registration Number
    8031509
    FEI Number
    3005176386
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6-1-12, TANASHI-CHO
    City
    NISHI-TOKYO-SHI
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K041516

    Owner / Operator

    Firm Name
    CITIZEN SYSTEMS JAPAN CO., LTD.
    Operator Number
    8031509
    Address
    6-1-12, Tanashi-cho, --
    City
    Nishi-Tokyo-shi
    State
    JP-13
    Postal Code
    188-8511
    Country
    JP

    US Agent

    Business Name
    FOLEY & LARDNER
    Contact Name
    Nathan Beaver
    Address
    3000 K STREET, N.W., SUITE 500
    City
    WASHINGTON
    State
    DC
    ZIP
    20007
    Country
    US
    Email
    [email protected]
    Phone
    202 6725300

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Citizen Systems Japan CTA301, CTA302, CTA303 Citizen Systems CH-650 Citizen Systems CH-657 Citizen Systems CH-456 Citizen Systems CH-452 Citizen Systems CH-4532 Citizen Systems CH-453 CH-308B Citizen Systems Japan CH607 Citizen Systems Japan CH-618 Citizen Systems Japan CH-617 Citizen Systems Japan CH605

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198