BEUDAMED
    EU Manufacturer 🇰🇷 South Korea Active

    T&R Biofab Co.,Ltd.

    SRN: KR-MF-000026617 · 96, Mayu-ro, Siheung-si, Gyeonggi-do, Republic of Korea, 15111 Siheung-si, Gyeonggi-do, South Korea
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    Basic UDI-DIs
    1
    Total Devices
    1
    On Market
    1
    Off Market
    0
    Certificates
    2
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    96, Mayu-ro, Siheung-si, Gyeonggi-do, Republic of Korea, 15111 Siheung-si, Gyeonggi-do, South Korea
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Mdd 1
    Classification
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    Eu Md Class 3 1
    Device Types
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    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    0
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II (excluding section 4) CE-MED-0067/04/2020/01 Dec 31, 2027
    MDD Annex II Section 4 CE-MED-0067/04/2020/01/DD.01 Dec 31, 2027

    Market Presence

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

    🇬🇷 Greece

    Device Portfolio

    Name
    FACIAL PROSTHESES - OTHER