BEUDAMED
    FDA Registration Active 🇨🇳 China

    AMSafe® Pre-Filled Normal Saline Flush Syringe

    Reg #: 3016413378 · FEI: 3016413378 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JIAXING TIANHE PHARMACEUTICAL CO., LTD.
    Registration Number
    3016413378
    FEI Number
    3016413378
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zhongfa Foreign Trade Industrial Zone, Fengaiao Town, Nanhu District,
    City
    Jiaxing Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213522

    Owner / Operator

    Firm Name
    Jiaxing Tianhe Pharmaceutical Co., Ltd.
    Operator Number
    10084601
    Address
    Zhongfa Foreign Trade Industrial Zone, Fengqiao Town, Nanhu District,
    City
    Jiaxing
    State
    Zhejiang
    Postal Code
    314008
    Country
    CN
    Correspondent
    Holiven Ji

    US Agent

    Business Name
    Amsino International Inc.
    Contact Name
    Gavin Zhang
    Address
    708 Corporate Center Drive
    City
    Pomona
    State
    CA
    ZIP
    91768
    Country
    US
    Email
    [email protected]
    Phone
    909 6265888 ext. 0

    Products

    Device Name Product Code
    Saline, Vascular Access Flush NGT

    Proprietary Names

    AMSafe® Pre-Filled Normal Saline Flush Syringe

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)