BEUDAMED
    FDA Registration Active 🇨🇳 China

    ZHANGZHOU AOXI PLASTIC CO., LTD.

    Reg #: 3004127962 · FEI: 3004127962 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    ZHANGZHOU AOXI PLASTIC CO., LTD.
    Registration Number
    3004127962
    FEI Number
    3004127962
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No 6 Yonghui Road, YANXI TOWN, CHANGTAI DISTRICT
    City
    ZHANGZHOU Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K052843

    Owner / Operator

    Firm Name
    ZHANGZHOU AOXI PLASTIC CO., LTD.
    Operator Number
    9058002
    Address
    MINYING INDUSTRIAL DISTRICT, YANXI TOWN, CHANGTAI
    City
    ZHANGZHOU, FUJIAN
    State
    CN-NOTA
    Postal Code
    363902
    Country
    CN
    Correspondent
    PETER JAMES - BOYLE

    US Agent

    Business Name
    Busse Hospital Disposables
    Contact Name
    Brenda Rojas
    Address
    75 Arkay Drive
    City
    Hauppauge
    State
    NY
    ZIP
    11788
    Country
    US
    Email
    [email protected]
    Phone
    800 6456526 ext. 218

    Products

    Device Name Product Code
    Urinary Drainage Collection Kit, For Indwelling Catheter FCN
    Container, Specimen, Sterile FMH
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Curette, Uterine HCY
    Needle, Hypodermic, Single Lumen FMI
    Tray, Surgical, Instrument FSM
    Amniotome HGE

    Proprietary Names

    FOR INDWELLING CATHETER GASTROENTE URINARY DRAINAGE COLLECTION ROLOGY-UROLO SPECIMEN STERILE#GENERAL HOSPITAL NON-STERILE#GENERAL HOSPITAL ABSORBENT TIPPED CURETTE UTERINE OBSTETRICS AND GYNECOLOGY SAF-T-CUBE tray, surgical instrument amniotome

    Establishment Types

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