BEUDAMED
    FDA Registration Active 🇨🇳 China

    Disposable Injection Needle

    Reg #: 3009064553 · FEI: 3009064553 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD.
    Registration Number
    3009064553
    FEI Number
    3009064553
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25D, HEYI BUSINESS PLAZA, NO. 420 JIANGNING RD.,JINGAN
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K142144

    Owner / Operator

    Firm Name
    SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD.
    Operator Number
    10056224
    Address
    25D, HEYI BUSINESS PLAZA, NO. 420 JIANGNING RD.,JINGAN
    City
    SHANGHAI
    State
    CN-SH
    Postal Code
    200041
    Country
    CN

    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
    Endoscopic Injection Needle, Gastroenterology-Urology FBK

    Proprietary Names

    Disposable Injection Needle

    Establishment Types

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