BEUDAMED
    FDA Registration Active 🇨🇳 China

    Safety hypodermic needle with syringe/Guardian ShieldTM hypodermic needle with syringe

    Reg #: 3012116434 · FEI: 3012116434 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
    Registration Number
    3012116434
    FEI Number
    3012116434
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 2 Guanyin Road Economic Development
    City
    Taihu Anhui
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K190183

    Owner / Operator

    Firm Name
    Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
    Operator Number
    10052857
    Address
    No. 2 Guanyin Road, Economic Development Zone, Taihu
    City
    Anqing
    State
    Anhui
    Postal Code
    246400
    Country
    CN
    Correspondent
    Birrell Xiang

    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
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Antistick MEG

    Proprietary Names

    Safety hypodermic needle with syringe/Guardian ShieldTM hypodermic needle with syringe Safety hypodermic needle/Guardian ShieldTM hypodermic needle

    Establishment Types

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