BEUDAMED
    FDA Registration Active 🇨🇳 China

    GUANGDONG BIOLIGHT MEDITECH CO., LTD

    Reg #: 3007305624 · FEI: 3007305624 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    GUANGDONG BIOLIGHT MEDITECH CO., LTD
    Registration Number
    3007305624
    FEI Number
    3007305624
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.9 Yonghe Road, Hi-tech Zone
    City
    Zhuhai Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K131763

    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
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Oximeter DQA
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Computer, Blood-Pressure DSK
    Monitor, St Segment With Alarm MLD
    Detector And Alarm, Arrhythmia DSI
    Plethysmograph, Impedance DSB
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Monitor, Breathing Frequency BZQ
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Oximeter, Infrared, Sporting, Aviation OCH
    Electrocardiograph DPS

    Proprietary Names

    Truscope Elite A8,Truscope Elite A6,Truscope Elite A5,Truscope Elite A3 patient monitor Truscope Classic,Truscope II,Truscope MINI patient monitor Fingertip Pulse Oximeters M70A, M70B,M70C M8000A, M9000A Patient Monitor TRUSCOPE II, TRUSCOPE mini, ARGUS CSM Patient Monitor M69, M7000, M8000, M9000 Patient Monitor M700 Handheld Pulse Oximeter M70 Fingertip Pulse Oximeter Vital Signs Monitor VS1 Vital Signs Monitor V6 Vital Signs Monitor PMVSM5000 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D AnyView A8,AnyView A6,AnyView A5, AnyView A3,Q2,Q3,Q4,Q5,Q6,Q7 Patient monitor V9 Vital Signs Monitor PMVSM9000 Vital Signs Monitor M50, M50A, M50L oximeter GPD-PO1GR01C AnyView A8, AnyView A6 and M9500 Patient Monitor ARGUS LSM Pro, ARGUS LSM Patient Monitor TRUSCOPE classic Patient Monitor WBP100,WBP201,WBP202 Electronic Sphygmomanometer AnyView A8, AnyView A6, AnyView A5, AnyView A3 patient monitor PATIENT MONITOR M8500 M800, ARGUS OXM plus Handheld Pulse Oximeter M800 Handheld Monitor E70 Digital Electrocardiograph E80 Digital Electrocardiograph E30 Digital Electrocardiograph M8000/M9000/M8000A/M9000A patient monitor

    Establishment Types

    Manufacture Medical Device