BEUDAMED
    FDA Registration Active 🇮🇳 India

    L12-4

    Reg #: 3033527241 · FEI: 3033527241 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    50
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips Global Business Services LLP - Ultrasound Business Unit
    Registration Number
    3033527241
    FEI Number
    3033527241
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5th Floor, Amar Madhuban Tech Park
    City
    Baner Pune Maharashtra
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K172607

    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 Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    L12-4 EPIQ 5W Diagnostic Ultrasound System X14-3 Affiniti 50 Diagnostic Ultrasound System D2tcd V6-2 EPIQ 7C Diagnostic Ultrasound System X7-2 S5-1 C9-4v X6-1 EPIQ 7G Diagnostic Ultrasound System C8-5 VL13-5 Affiniti 70G Diagnostic Ultrasound System S8-3t X8-2t S4-2 Affiniti 50W Diagnostic Ultrasound System C9-2 Affiniti 70W Diagnostic Ultrasound System eL18-4 D5cwc 3D9-3v L15-7io Affiniti 70C Diagnostic Ultrasound System C10-4ec D2cwc S7-3t Affiniti 70 Diagnostic Ultrasound System L12-3 BP10-5ec C6-2 EPIQ 7W Diagnostic Ultrasound System L12-5 50 X5-1 S8-3 EPIQ 5G Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System Affiniti 50C Diagnostic Ultrasound System S12-4 L18-5 C5-1 C10-3v X7-2t X8-2ti EPIQ Diagnostic Ultrasound System EPIQ 5 Diagnostic Ultrasound System Affiniti 50G Diagnostic Ultrasound System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility