BEUDAMED
    FDA Registration Active 🇨🇳 China

    Accuryn Monitoring System

    Reg #: 3020978007 · FEI: 3020978007 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    DONGGUAN BAO KANG DIAN ZI KE JI LIMITED
    Registration Number
    3020978007
    FEI Number
    3020978007
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 8-1, Wen Yu Road, Zhangmutou Town
    City
    Dongguan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221020

    Owner / Operator

    Firm Name
    HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
    Operator Number
    9058334
    Address
    Units 15-21, 12/F, Topsail Plaza,, 11 On Sum Street,
    City
    Shek Mun, Shatin
    State
    HK-NOTA
    Postal Code
    --
    Country
    HK

    US Agent

    Business Name
    Law Offices Of Albert Wai-Kit Chan
    Contact Name
    Albert Wai-Kit Chan
    Address
    Law Offices Of Albert Wai-Kit Chan, PLLC World Plaza, Suite 604 141-07 20th Avenue
    City
    Whitestone
    State
    NY
    ZIP
    11357
    Country
    US
    Email
    [email protected]
    Phone
    718 7991000

    Products

    Device Name Product Code
    Intra-Abdominal Pressure Monitoring Device PHU
    Medical Device Data System OUG
    Uroflowmeter EXY
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Accuryn Monitoring System Accuryn SmartFoley IAP UO Temp Tray System Accuryn SmartFoley UO Temp Tray System AccuTab

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)