BEUDAMED
    FDA Registration Active 🇨🇳 China

    Nitrile Disposable Examination Gloves

    Reg #: 3018779144 · FEI: 3018779144 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    XINGYU MEDICAL TECH CO.,LTD
    Registration Number
    3018779144
    FEI Number
    3018779144
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.2189 Yaoqian Road, Gaomi Economic Development Zone
    City
    Weifang Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233990

    Owner / Operator

    Firm Name
    Xingyu Medical Tech Co.,Ltd
    Operator Number
    10081106
    Address
    No.2189 Yaoqian Road, Gaomi Economic Development Zone
    City
    Weifang
    State
    Shandong
    Postal Code
    261500
    Country
    CN
    Correspondent
    Chongyu Xu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA
    Fentanyl And Other Opioid Protection Glove QDO

    Proprietary Names

    Nitrile Disposable Examination Gloves

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)