BEUDAMED
    FDA Registration Active 🇨🇳 China

    ONE-CARE safety pen needle

    Reg #: 3004496829 · FEI: 3004496829 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Berpu Medical Technology Co., Ltd.
    Registration Number
    3004496829
    FEI Number
    3004496829
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.14 Xingji Road, Yongxing Street, Longwan District
    City
    WENZHOU Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K181447

    Owner / Operator

    Firm Name
    Berpu Medical Technology Co., Ltd.
    Operator Number
    9061974
    Address
    No. 14 Xingji Road, Yongxing Street, Longwan Distric
    City
    Wenzhou
    State
    Zhejiang
    Postal Code
    325000
    Country
    CN

    US Agent

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

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    ONE-CARE safety pen needle

    Establishment Types

    Manufacture Medical Device