BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.

    Reg #: 3013500228 · FEI: 3013500228 · Expires 2025
    View on FDA
    Products
    33
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    33

    Registration Details

    Registration Name
    Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
    Registration Number
    3013500228
    FEI Number
    3013500228
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit A, 27/F Railway Plaza, 39 Chatham Road South
    City
    Tsimshatsui, Kowloon
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K131414

    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, Breathing Frequency BZQ
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Electrocardiograph DPS
    Computer, Blood-Pressure DSK
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Computer, Oxygen-Uptake BZL
    Alarm, Blood-Pressure DSJ
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Oximeter DQA
    Reduced- Montage Standard Electroencephalograph OMC
    Probe, Thermodilution KRB
    Computer, Diagnostic, Programmable DQK
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, St Segment With Alarm MLD
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Detector And Alarm, Arrhythmia DSI
    Stimulator, Nerve, Peripheral, Electric KOI
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Stimulator, Auditory, Evoked Response GWJ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Burst Suppression Detection Software For Electroencephalograph ORT
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Oximeter, Ear DPZ

    Establishment Types

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