BEUDAMED
    FDA Registration Active 🇨🇳 China

    21369A (Omni II)

    Reg #: 3005403518 · FEI: 3005403518 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips Ultrasound (Shanghai) Co., Ltd
    Registration Number
    3005403518
    FEI Number
    3005403518
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 5, 3000 Longdong Boulevard, Suite 102, Suite 203, Suite 702
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K014191

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

    Proprietary Names

    21369A (Omni II) 21228B (D1914V) S4-2 21321A (C3540) C9-4ec 21360A (L5035) 21373B (C5040) 21422A C8-4v C5-2 21221B (C1914C) 21330A (S4) 21350A (S8) 21475A C6-3 21359A (L7535) C8-5 21390A (15-61) EnVisor Diagnostic Ultrasound System 21223B (D5014V) 21380A (S12) S4

    Establishment Types

    Manufacture Medical Device