BEUDAMED
    FDA Registration Active 🇨🇳 China

    Shandong Ande Healthcare Apparatus Co., Ltd.

    Reg #: 3012039263 · FEI: 3012039263 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Shandong Ande Healthcare Apparatus Co., Ltd.
    Registration Number
    3012039263
    FEI Number
    3012039263
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 999, Zunxian Road, New & Hi-Tech Zone,
    City
    Zibo Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K202060

    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
    Meng Zhang

    US Agent

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

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Piston FMF
    Syringe, Antistick MEG
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Enteral Syringes With Enteral Specific Connectors PNR
    Set, Administration, Intravascular FPA

    Proprietary Names

    Disposable IV catheter Auto-disable Syringe for Fixed-dose Immunization Closed System Transfer Device Disposable Enteral Syringe Disposable Extension Set Intravascular administration set with 0.2micron filter and flow regulator AD0401 Intravascular administration set with 0.2micron filter AD0301 Intravascular administration set with 1.2micron filter and needlefree Y access port and check valve AD05 Intravascular administration set with 1.2micron filter AD0501 Intravascular administration set with flow regulator and needlefree Y access port and check valve AD02 Intravascular administration set with 0.2micron filter and needlefree Y access port and check valve AD03 Intravascular administration set with 0.2micron filter and flow regulator and needlefree Y access port and check valve Intravascular administration set with flow regulator and needlefree Y access port and check valve AD01 Intravascular administration set AD0101 Intravascular administration set with flow regulator AD0201 Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

    Establishment Types

    Manufacture Medical Device