BEUDAMED
    FDA Registration Active 🇮🇳 India

    L12-5 50

    Reg #: 3033527283 · FEI: 3033527283 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    59
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips India Limited - Ultrasound Business Unit
    Registration Number
    3033527283
    FEI Number
    3033527283
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
    City
    Bengaluru Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K182857

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Ondrea Bermudez
    Address
    3721 Valley Centre Dr
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US
    Email
    [email protected]
    Phone
    443 3200028

    Products

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

    Proprietary Names

    L12-5 50 mC7-2 Affiniti 50C Diagnostic Ultrasound System X7-2 S12-4 eL18-4 S5-1 C10-3v Affiniti 50W Diagnostic Ultrasound System EPIQ CVxi Diagnostic Ultrasound System S7-3t X8-2ti S8-3t EPIQ 5 Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System L15-7io EPIQ 7W Diagnostic Ultrasound System Affiniti 50G Diagnostic Ultrasound System EPIQ CVx Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System C9-2 C9-4v VL13-5 Affiniti 70C Diagnostic Ultrasound System C5-1 C10-4ec V9-2 D5cwc L18-5 EPIQ 5G Diagnostic Ultrasound System D2tcd BP10-5ec L12-3 ERGO EPIQ Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System X5-1 S9-2 Affiniti 70G Diagnostic Ultrasound System L12-4 X6-1 L12-3 C6-2 X7-2t EPIQ Elite W Diagnostic Ultrasound System S4-2 EPIQ 7C Diagnostic Ultrasound System S8-3 EPIQ Elite Diagnostic Ultrasound System C8-5 Affiniti 70 Diagnostic Ultrasound System V6-2 3D9-3v D2cwc Affiniti 70W Diagnostic Ultrasound System XL14-3 X8-2t X5-1c

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility