BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EDAN Diagnostics, Inc.

    Reg #: 3009499478 · FEI: 3009499478 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    35

    Registration Details

    Registration Name
    EDAN Diagnostics, Inc.
    Registration Number
    3009499478
    FEI Number
    3009499478
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9918 Via Pasar
    City
    San Diego
    State
    CA
    ZIP
    92126
    Country
    US

    Owner / Operator

    Firm Name
    EDAN Diagnostics, Inc.
    Operator Number
    10043671
    Address
    9918 Via Pasar
    City
    San Diego
    State
    CA
    Postal Code
    92126
    Country
    US
    Correspondent
    Annie P Wright

    Products

    Device Name Product Code
    Detector And Alarm, Arrhythmia DSI
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Transducer, Ultrasonic, Obstetric HGL
    System, Monitoring, Perinatal HGM
    Oximeter DQA
    Electrocardiograph DPS
    Continuous Measurement Thermometer FLL
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Electrode, Cutaneous GXY
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Breathing Frequency BZQ
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Computer, Blood-Pressure DSK
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Recorder, Magnetic Tape, Medical DSH
    Plethysmograph, Impedance DSB
    Monitor, Blood-Flow, Ultrasonic HEP
    Monitor, Ultrasonic, Fetal KNG
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Computer, Diagnostic, Programmable DQK
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Spirometer, Monitoring (W/Wo Alarm) BZK
    System, Network And Communication, Physiological Monitors MSX

    Proprietary Names

    Fetal & maternal monitor: F6 Express Fetal monitor: F2 Fetal & maternal monitor: F9 Express Fetal & maternal monitor: F6 Fetal & maternal monitor: F9 Fetal monitor: F3 Patient Monitor: iM20 Telemetry Transmitter: iT20 Patient Monitor: X10 Patient Monitor: X8 Patient Monitor: X12 Central Monitoring System: MFM-CNS Lite Central Monitoring System: MFM-CNS Patient Monitor: iX15 Patient Monitor: iX10 Patient Monitor: iX12 Holter ECG and ABP system: SA-20 Patient Monitor: RespArray Vital Signs Monitor, model: M3B Ultrasonic pocket Doppler: SonoTrax Basic Diagnostic Ultrasound System: Acclarix AX9 Patient Monitor: iM50 Patient Monitor: iM60 Patient Monitor: iM80 Patient Monitor: iM70 Holter System: SE-2003 Vital Signs Monitor, model: iM3s Patient Monitor: iM8 Ambulatory Blood Pressure Monitor: SA-10 Vital Signs Monitor, model: iM3 Vital Signs Monitor, model: M3A Vital Signs Monitor, model: M3 Patient Monitor: elite V5 Patient Monitor: elite V8 Patient Monitor: elite V6 Electrocardiograph: SE-1200 Express Pulse Oximeter: H100B Central Monitoring System: MFM-CMS Digital Ultrasonic Diagnostic Imaging System: DUS 60 PC ECG: SE-1515

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)