BEUDAMED
    FDA Registration Active 🇮🇳 India

    L8-18i-RS

    Reg #: 3032109181 · FEI: 3032109181 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED
    Registration Number
    3032109181
    FEI Number
    3032109181
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 4 Kadugodi Industrial Area, Sadarmangala, Whitefield
    City
    Bangalore Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K210438

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    L8-18i-RS 6S-RS RIC5-9A-RS 3Sc-RS E8C-RS C1-5-RS L3-12-RS L6-12-RS 9L-RS 12L-RS 4C-RS E8Cs-RS BE9CS-RS Versana Premier 8C-RS E7C8L-RS LK760-RS RAB2-6-RS 12S-RS

    Establishment Types

    Manufacture Medical Device