The user and/or patient should report any serious incidents that have occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
Report to manufacturer at:
Telephone: +82-02-2193-9600
Website: www.medit.com
email: support@medit.com
Report to local authority at:
FDA MAUDE http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm |
MHRA (Medicines & Healthcare products Regulatory Agency): Medical device alert |
BfArM : Medical device alert https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html |
MFDS (Ministry of Food and Drug Safety) : Medical device alert http://www.mfds.go.kr/brd/m_548/list.do https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm |
European_EUDAMED |
Australia |
Canada |
Brazil |
Japan https://www.estrigw.pmda.go.jp/Iryo/Login/Index?ReturnUrl=%2fIryo |
Taiwan |
Switzerland |