BEUDAMED
    FDA Registration Active 🇨🇳 China

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

    Reg #: 3020978007 · FEI: 3020978007 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    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
    K153655

    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
    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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)