BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    UltraConnect UB-1100BLE Blood Pressure Monitor

    Reg #: 3003864328 · FEI: 3003864328 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    A&D Company, Limited - Tech Center
    Registration Number
    3003864328
    FEI Number
    3003864328
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-243 Asahi
    City
    Kitamoto-shi Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K170196

    Owner / Operator

    Firm Name
    A&D Company, Limited
    Operator Number
    8031633
    Address
    3-23-14 HIGASHI-IKEBUKURO
    City
    TOSHIMA-KU
    State
    Tokyo
    Postal Code
    170-0013
    Country
    JP

    US Agent

    Business Name
    A&D Engineering, Inc.
    Contact Name
    Adam Huddle
    Address
    4622 Runway Boulevard
    City
    Ann Arbor
    State
    MI
    ZIP
    48108
    Country
    US
    Email
    [email protected]
    Phone
    734 2095821

    Products

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

    Proprietary Names

    UltraConnect UB-1100BLE Blood Pressure Monitor

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility