BEUDAMED
    FDA Registration Active 🇨🇳 China

    Closed System Transfer Device

    Reg #: 3012039263 · FEI: 3012039263 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shandong Ande Healthcare Apparatus Co., Ltd.
    Registration Number
    3012039263
    FEI Number
    3012039263
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 999, Zunxian Road, New & Hi-Tech Zone,
    City
    Zibo Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K201460

    Owner / Operator

    Firm Name
    Shandong Ande Healthcare Apparatus Co., Ltd.
    Operator Number
    10056160
    Address
    No. 999, Zunxian Road, New & Hi-Tech Zone,
    City
    Zibo
    State
    Shandong
    Postal Code
    255086
    Country
    CN
    Correspondent
    Wanjie Liang

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., LTD
    Contact Name
    Marco Mu
    Address
    2219 Rimland Dr. Suite 301
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB

    Proprietary Names

    Closed System Transfer Device

    Establishment Types

    Manufacture Medical Device