BEUDAMED
    FDA Registration Active 🇨🇳 China

    CareTouch Lancet

    Reg #: 9616530 · FEI: 3003116995 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
    Registration Number
    9616530
    FEI Number
    3003116995
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 35 and 37, YINGCHENG STREET, HANGU, BINHAI NEW AREA
    City
    TIANJIN
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K220475

    Owner / Operator

    Firm Name
    TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
    Operator Number
    9047576
    Address
    No. 35 and 37, Yingcheng Street, Hangu Binhai New Area
    City
    Tianjin
    State
    CN-NOTA
    Postal Code
    300480
    Country
    CN
    Correspondent
    YOUNG DO Kim

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

    Device Name Product Code
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    CareTouch Lancet CareTouch Lancing Device

    Establishment Types

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