BEUDAMED
    FDA Registration Active 🇮🇳 India

    SKANRAY TECHNOLOGIES LIMITED

    Reg #: 3009001657 · FEI: 3009001657 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    20
    Establishment Types
    3
    Classifications
    25

    Registration Details

    Registration Name
    SKANRAY TECHNOLOGIES LIMITED
    Registration Number
    3009001657
    FEI Number
    3009001657
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Plot# 15-17, Hebbal Industrial Area, Hebbal
    City
    Mysore Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K220518

    Owner / Operator

    Firm Name
    Skanray Technologies Limited
    Operator Number
    10036010
    Address
    Plot #15-17, Hebbal Industrial Area, Hebbal
    City
    Mysore
    State
    Karnataka
    Postal Code
    570016
    Country
    IN
    Correspondent
    Vasundhara R

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter DQA
    Ventilatory Effort Recorder MNR
    Unit, X-Ray, Extraoral With Timer EHD
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Transducer, Blood-Pressure, Extravascular DRS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Continuous Measurement Thermometer FLL
    Probe, Thermodilution KRB
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Recorder, Paper Chart DSF
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Alarm, Blood-Pressure DSJ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    System, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    SKANRAD 400 STAR 60 - TruSKAN S500 STAR 60 STAR 60 - TruSKAN S600 STAR 90 Capnostream 20P XZeal Z70 DC INTRASKAN DC INTRASKAN DC PLUS IMAGESCAN HD INTRA SKAN DC Skyline 55 SpotSkan Skan C Capnostream Star 65 Capnostream 20P with HiFi CO2 monitoring Skanmobile Dr Skanmobile PodSKAN HF Diagnostic X-ray System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)