BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HEALCERION CO., LTD

    Reg #: 3011648943 · FEI: 3011648943 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    HEALCERION CO., LTD
    Registration Number
    3011648943
    FEI Number
    3011648943
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1013-Ho, 12 Digital-Ro 33-Gil, Guro-Gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K151339

    Owner / Operator

    Firm Name
    Healcerion Co., Ltd.
    Operator Number
    10049969
    Address
    1013-Ho, 12 Digital-Ro 33-Gil, Guro-Gu
    City
    Seoul
    State
    KR-11
    Postal Code
    08377
    Country
    KR
    Correspondent
    Jeogwon Ryu

    US Agent

    Business Name
    Provision Consulting Group, Inc.
    Contact Name
    Joyce Kwon
    Address
    13925 City Center Dr Ste 200
    City
    Chino Hills
    State
    CA
    ZIP
    91709
    Country
    US
    Email
    [email protected]
    Phone
    909 4933276

    Products

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

    Proprietary Names

    SONON Ultrasound Imaging System (Model: SONON 300C) SONON Ultrasound Imaging System (Model: 300L) SONON Ultrasound Imaging System (Model: SONON 500L)

    Establishment Types

    Manufacture Medical Device