BEUDAMED
    FDA Registration Active 🇨🇳 China

    Dora Disposable A.V. Fistula Needle Sets

    Reg #: 3010187826 · FEI: 3010187826 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GUANGZHOU HUADA BIOTECHNOLOGY CO., LTD.
    Registration Number
    3010187826
    FEI Number
    3010187826
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 84,Banhe Road,Guangzhou, High-Tech Industrial Development Zone
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K163025

    Owner / Operator

    Firm Name
    Guangzhou Huada Biotechnology Co., Ltd.
    Operator Number
    10043265
    Address
    No.84, Banhe Road,Guangzhou High-Tech Industrial Development Zone
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510530
    Country
    CN
    Correspondent
    Yingjie Gu

    US Agent

    Business Name
    SOUTH BAY INNOVATION LLC
    Contact Name
    Yueting Zhu
    Address
    23545 Crenshaw Blvd Ste 106
    City
    Torrance
    State
    CA
    ZIP
    90505
    Country
    US
    Email
    [email protected]
    Phone
    424 3769142

    Products

    Device Name Product Code
    Needle, Fistula FIE

    Proprietary Names

    Dora Disposable A.V. Fistula Needle Sets

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)