BEUDAMED
    FDA Registration Active 🇨🇳 China

    Amphenol Medical Technologies (Dongguan) Co., Ltd.

    Reg #: 3013596024 · FEI: 3013596024 · Expires 2026
    View on FDA
    Products
    77
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    77

    Registration Details

    Registration Name
    Amphenol Medical Technologies (Dongguan) Co., Ltd.
    Registration Number
    3013596024
    FEI Number
    3013596024
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.2 Xinhu Industrial 1st Street, Qiaotou
    City
    Dongguan Guangdong
    Country
    CN

    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
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Electrocardiograph DPS
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Automated External Defibrillators (Non-Wearable) MKJ
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    System, Monitoring, Perinatal HGM
    Electrode, Cutaneous GXY
    Detector And Alarm, Arrhythmia DSI
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    System, Network And Communication, Physiological Monitors MSX
    Oximeter DQA
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Breathing Frequency BZQ
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Computer, Blood-Pressure DSK
    Full-Montage Standard Electroencephalograph GWQ
    Adjunctive Open Loop Fluid Therapy Recommender QMS
    Cable ISN
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Pulse Generator, Permanent, Implantable NVZ
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD
    Aid, Cardiopulmonary Resuscitation LIX
    Oximeter, Ear DPZ
    Cable, Electrode IKD
    Analyzer, Gas, Nitrogen, Gaseous-Phase CCI
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Plethysmograph, Impedance DSB
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep. DOA
    Display, Cathode-Ray Tube, Medical DXJ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Helium, Gaseous-Phase BSE
    Probe, Blood-Flow, Extravascular DPT
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Argon, Gaseous-Phase JEG
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Catheter, Oximeter, Fiber-Optic DQE
    Computer, Diagnostic, Programmable DQK
    Oximeter, Tissue Saturation MUD
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Alarm, Blood-Pressure DSJ
    Computer, Oxygen-Uptake BZL
    Probe, Thermodilution KRB
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Stimulator, Nerve, Peripheral, Electric KOI
    Reduced- Montage Standard Electroencephalograph OMC
    Monitor, St Segment With Alarm MLD
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Index-Generating Electroencephalograph Software OLW
    Stimulator, Auditory, Evoked Response GWJ
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Burst Suppression Detection Software For Electroencephalograph ORT
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Analyzer, Spectrum, Electroencephalogram Signal GWS
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Recorder, Magnetic Tape, Medical DSH
    System, Balloon, Intra-Aortic And Control DSP
    Tester, Electrode, Surface, Electrocardiographic KRC
    Calculator, Pulmonary Function Data BZC
    Recorder, Paper Chart DSF
    Monitor, St Segment MLC
    Transducer, Blood-Pressure, Extravascular DRS
    System, Signal Isolation DRJ
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Adaptor, Lead Switching, Electrocardiograph DRW

    Proprietary Names

    CABLE,MULTI FUNCTION,DPLX SHLD,7.5FT Bovie Cord:Reusable Bipolar Forceps Cord Kendall DL 12 Pin Adapter ECG lead, Multi and Monolead ECG lead, reusable CABLE ECG X2 3/5-LD PHILIPS AHA 20CM/9IN Cable SpaceLabs None Spacelabs Medical Ultraview Digital Telemetry System- Leadwire Set

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)