BEUDAMED
    FDA Registration Active 🇨🇳 China

    TonmiCare Pen Needles

    Reg #: 3010515547 · FEI: 3010515547 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PROMISEMED HANGZHOU MEDITECH CO.,LTD.
    Registration Number
    3010515547
    FEI Number
    3010515547
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 1388 Cangxing Street,, Cangqian Community, Yuhang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242632

    Owner / Operator

    Firm Name
    Promisemed Hangzhou Meditech Co.,Ltd.
    Operator Number
    10045479
    Address
    No. 1388 Cangxing Street, Cangqian Community, Yuhang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311121
    Country
    CN
    Correspondent
    Frank Zhang

    US Agent

    Business Name
    PROMISEMED USA
    Contact Name
    Robert Wernsman
    Address
    506 W. Rhapsody Dr.
    City
    San Antonio
    State
    TX
    ZIP
    78216
    Country
    US
    Email
    [email protected]
    Phone
    954 7320415

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    TonmiCare Pen Needles Verifine Plus Insulin Pen Needles Verifine Insulin Pen Needles Verifine Plus Pen Needles Sensifine Pen Needles TonmiCare PLUS Pen Needles Verifine Pen Needles

    Establishment Types

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