44 results
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52ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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-...
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
RUICHUANGKE DIGITAL CO. LTD
FDA registration
RUICHUANGKE DIGITAL CO. LTD·1 product·🇨🇳 China
SUNSTAR DIGI (H.K.) CO., LTD
FDA registration
SUNSTAR DIGI (H.K.) CO., LTD·1 product·🇨🇳 China
SHENZHEN 3NOD DIGITAL TECHNOLOGY CO., LTD
FDA registration
SHENZHEN 3NOD DIGITAL TECHNOLOGY CO., LTD·1 product·🇨🇳 China
SHENZHEN KESITE DIGITAL TECHNOLOGY CO., LTD.
FDA registration
SHENZHEN KESITE DIGITAL TECHNOLOGY CO., LTD.·3 products·🇨🇳 China
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.
FDA registration
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.·2 products·🇨🇳 China
SHENZHEN RANVOO DIGITAL TECHNOLOGY CO., LTD.
FDA registration
SHENZHEN RANVOO DIGITAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China
GUANGZHOU SOWEN DIGITAL TECHNOLOGY CO., LTD.
FDA registration
GUANGZHOU SOWEN DIGITAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China
X-ray Flat Panel Detector
FDA UDI
CareRay Digital Medical Technology Co., Ltd.·06970597830097·