BEUDAMED
    FDA Registration Active 🇨🇳 China

    Blood Pressure Monitor

    Reg #: 9680638 · FEI: 3005667208 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CARDICARE COMPANY, LTD.
    Registration Number
    9680638
    FEI Number
    3005667208
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    27 Huashan Road Gaochun Economy Zone
    City
    NANJING Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K082542

    Owner / Operator

    Firm Name
    CARDICARE COMPANY, LTD.
    Operator Number
    9010325
    Address
    9 YAN AN ROAD, WU SHAN PLAZA TOWN, UNIT 7003
    City
    HANGZHOU
    State
    Zhejiang
    Postal Code
    310002
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Blood Pressure Cuff DXQ

    Proprietary Names

    Blood Pressure Monitor W03-01001,Wyltec Blood pressure cuff Model HBPK-A,SP-CB-002

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device