BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.

    Reg #: 3013500228 · FEI: 3013500228 · Expires 2026
    View on FDA
    Products
    77
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    77

    Registration Details

    Registration Name
    Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
    Registration Number
    3013500228
    FEI Number
    3013500228
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit A, 27/F Railway Plaza, 39 Chatham Road South
    City
    Tsimshatsui, Kowloon
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K211651
    PMA Number
    P030054

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

    Proprietary Names

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

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device