BEUDAMED
    FDA Registration Active 🇨🇳 China

    Medisign GH82 Blood Glucose Monitoring System

    Reg #: 9616530 · FEI: 3003116995 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    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
    K162564

    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
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Medisign GH82 Blood Glucose Monitoring System Medisign GH81 Blood Glucose Monitoring System Medisign GH83 BT Blood Glucose Monitoring System Medisign GH83 Blood Glucose Monitoring System Medisign GH81 BT Blood Glucose Monitoring System Medisign GH82 BT Blood Glucose Monitoring System Prove GH82 Blood Glucose Test Strip Prove GH82 Blood Glucose Monitoring System Prove GH Glucose Control Solution

    Establishment Types

    Manufacture Medical Device