BEUDAMED
    EU Manufacturer 🇰🇷 South Korea Inactive

    AI INSIGHT INC.

    SRN: KR-MF-000016123 · Busandaehak-ro 63beon-gil 604, 2, 46241 Busan, South Korea
    View on EUDAMED
    Basic UDI-DIs
    1
    Total Devices
    1
    On Market
    1
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Busandaehak-ro 63beon-gil 604, 2, 46241 Busan, South Korea
    Email
    [email protected]
    Phone
    +82 51 254 7715
    Website
    https://aiinsight.io/

    Regulatory Overview

    Regulation
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    Eu Mdd 1
    Classification
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    Eu Md Class 2a 1
    Device Types
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    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) 1434-MDD-370/2021 May 27, 2024

    Market Presence

    Devices from this manufacturer are available in 1 country across Europe.

    🇵🇱 Poland

    Device Portfolio

    Name
    VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE