BEUDAMED
    FDA Registration Active 🇨🇳 China

    Amphenol Medical Technologies (Dongguan) Co., Ltd.

    Reg #: 3013596024 · FEI: 3013596024 · Expires 2025
    View on FDA
    Products
    39
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    39

    Registration Details

    Registration Name
    Amphenol Medical Technologies (Dongguan) Co., Ltd.
    Registration Number
    3013596024
    FEI Number
    3013596024
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.2, Xinhu Industrial Park, Qiaolong Road, Dengwu Village, Qiaotou
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150310

    Owner / Operator

    Firm Name
    Amphenol Critical Medical Technologies, LLC
    Operator Number
    10053883
    Address
    9586 Distribution Avenue, Suite F
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US

    US Agent

    Business Name
    Amphenol Critical Medical Technologies, LLC
    Contact Name
    Lamont Rohde
    Address
    9586 Distribution Avenue, Suite F
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    602 7503539

    Products

    Device Name Product Code
    Alarm, Blood-Pressure DSJ
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Analyzer, Spectrum, Electroencephalogram Signal GWS
    Recorder, Magnetic Tape, Medical DSH
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Tester, Electrode, Surface, Electrocardiographic KRC
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Burst Suppression Detection Software For Electroencephalograph ORT
    Oximeter DQA
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    System, Balloon, Intra-Aortic And Control DSP
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    System, Network And Communication, Physiological Monitors MSX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Breathing Frequency BZQ
    Calculator, Pulmonary Function Data BZC
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Transducer, Blood-Pressure, Extravascular DRS
    Recorder, Paper Chart DSF
    Detector And Alarm, Arrhythmia DSI
    Monitor, St Segment MLC
    System, Signal Isolation DRJ
    Electrocardiograph DPS
    Probe, Thermodilution KRB
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, St Segment With Alarm MLD
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Stimulator, Nerve, Peripheral, Electric KOI
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Computer, Blood-Pressure DSK
    Adaptor, Lead Switching, Electrocardiograph DRW
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)