BEUDAMED
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    DIGIMED Co., Ltd.

    Manufacturer
    🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices·1 Importer·DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS

    DIGIMED CO., LTD

    FDA registration
    DIGIMED CO., LTD·1 product·🇰🇷 South Korea

    PROX

    FDA UDI
    DigiMed Co., Ltd.·08800021800007·The PROX is a hand-held diagnostic dental x-ray...

    MiniX-S

    FDA UDI
    DigiMed Co., Ltd.·08800021800021·The MiniX-S is an x-ray generating device which...

    DHX-70H

    FDA UDI
    DigiMed Co., Ltd.·08800021800137·The portable x-ray system, DHX-70H is an x-ray ...

    DIOX-602

    FDA UDI
    DigiMed Co., Ltd.·08800021800014·The DIOX-602 is a hand-held diagnostic dental x...

    BIOX

    FDA UDI
    DigiMed Co., Ltd.·08800021800045·The portable x-ray system, BIOX is an x-ray gen...

    xm-lite

    FDA UDI
    DigiMed Co., Ltd.·08800021800113·The portable x-ray system, HYBRID C70 is an x-r...

    XTG PRO 70

    FDA UDI
    DigiMed Co., Ltd.·08800021800120·The portable x-ray system, HYBRID Pro is an x-r...

    HYBRID S70

    FDA UDI
    DigiMed Co., Ltd.·08800021800106·The portable x-ray system, HYBRID S70 is an x-r...

    MiniX-V

    FDA UDI
    DigiMed Co., Ltd.·08800021800038·The MiniX-V is a hand-held diagnostic dental x-...

    EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY

    Device
    EU MDD · Eu Md Class 2b ·DIGIMED Co., Ltd.·On the market·1 country

    EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY

    Device
    EU MDD · Eu Md Class 2b ·DIGIMED Co., Ltd.·On the market·1 country

    EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY

    Device
    EU MDD · Eu Md Class 2b ·DIGIMED Co., Ltd.·On the market·1 country

    Portable X-ray system

    FDA Recall
    Open, Classified ·DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of)·Product code EHD·June 19, 2025

    Portable X-ray system

    FDA Enforcement
    Class II ·Ongoing·DIGIMED CO., LTD·July 30, 2025

    MINIX-S

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·DIGIMED Co., Ltd.·1 device

    PROX

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·DIGIMED Co., Ltd.·1 device

    DIOX-602

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·DIGIMED Co., Ltd.·1 device

    9898-2017-CE-KOR-PS

    Certificate
    MDD Annex II (excluding section 4)·DIGIMED Co., Ltd.·DNV Product Assurance AS·1 Basic UDI-DI