DIGIMED CO., LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30079332323007933232DIGIMED CO., LTD1N2026-01-01401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul KR 08505

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1231411489708023K221587DHX-70H, XTG-70HEHD2023-03-03
1231411005461043K220579Hybrid C70EHD2022-09-01
1231412041549541K220574HYBRID S70EHD2022-04-22
1231411815020518K181891Portable X-ray System (Model: MiniX-V, Mini X-S)EHD2018-08-10
1231412015855207K152859Portable X-ray System (Model: MINIX-V / MINIX-S)EHD2015-12-03
1231411711388031K103600PORTABLE X-RAY SYSTEMEHD2011-04-08
1231412002252655K082167PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROXEHD2008-09-26
1231411934213033

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EHD72023-03-03

PMN#