BEUDAMED
    FDA Registration Active 🇨🇳 China

    TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor

    Reg #: 3007305624 · FEI: 3007305624 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    GUANGDONG BIOLIGHT MEDITECH CO., LTD
    Registration Number
    3007305624
    FEI Number
    3007305624
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.9 Yonghe Road, Hi-tech Zone
    City
    Zhuhai Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K100046

    Owner / Operator

    Firm Name
    Guangdong Biolight Meditech Co., Ltd
    Operator Number
    10027195
    Address
    No.2 Innovation First Road, Technology, Innovation Coast, Hi-tech Zone
    City
    Zhuhai
    State
    Guangdong
    Postal Code
    519085
    Country
    CN
    Correspondent
    Jinyuan Yan

    US Agent

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

    Products

    Device Name Product Code
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Breathing Frequency BZQ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Oximeter DQA
    Computer, Blood-Pressure DSK

    Proprietary Names

    TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor M8000A, M9000A Patient Monitor M69, M7000, M8000, M9000 Patient Monitor

    Establishment Types

    Manufacture Medical Device