FDA.reportPublic FDA data

Intromed

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30136843283013684328IntroMedic Co., Ltd.1N2026-01-01F-RTEK 4F, 11-25, Simin-daero 327 beon-gil Dongan-gu Anyang-si Gyeonggi KR 14055
30166780393016678039INTROMEDIC AMERICA INC.1Y2026-01-0114450 Rhinestone St Nw Suite 221 Anoka M.N. 55303 Anoka MN US 55303

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2094762066580581K180732MiroCam Capsule Endoscope SystemNEZ2018-11-08
2094761241202940K170438MiroCam Capsule Endoscope SystemNEZ2018-01-30
2094761675575805K143663MiroCam Capsule Endoscope SystemNEZ2015-03-17
2094761862904166K140751MIROCAM CAPSULE ENDOSCOPE SYSTEMNEZ2014-06-30
2094761661963037K131131E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEMEOX2013-06-21
2094761886960109K123428MIROCAM CAPSULE ENDOSCOPE SYSTEMNEZ2013-05-20
2094761408870026K120702E.G. SCAN II ESPHAGOSCOPE SYSTEMEOX2012-06-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEZ52018-11-08
EOX22013-06-21

PMN#

GUDID#