BEUDAMED
    FDA Registration Active 🇮🇳 India

    STAR 60

    Reg #: 3009001657 · FEI: 3009001657 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SKANRAY TECHNOLOGIES LIMITED
    Registration Number
    3009001657
    FEI Number
    3009001657
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot# 15-17, Hebbal Industrial Area, Hebbal
    City
    Mysore Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K151512

    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

    US Agent

    Business Name
    Elexes Medical Consulting
    Contact Name
    Dana S
    Address
    218 Eclipse Drive, Bordentown
    City
    Bordentown
    State
    NJ
    ZIP
    08505
    Country
    US
    Email
    [email protected]
    Phone
    732 6475105 ext. 1

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    STAR 60 STAR 60 - TruSKAN S600 STAR 60 - TruSKAN S500

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device