M I One Co L T D

FDA Filings

This page includes the latest FDA filings for M I One Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3016245408
• FEI Number: 3016245408
• Name: M.I.ONE. CO.,LTD
• Owner & Operator: M.I.ONE. Co.,Ltd
• Contact Address: 161,Usangongdan-gil ; Wonju-si KR-42 Gangweondo 26335 KR
• Official Correspondent:
  • KIM TAEWOO
  • 82-33-7478607-x
• US Agent:
  • davekim
  • Mtech Group
  • 713 4672607
  • 713 4648880
  • davekim@mtech-inc.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 161,Usangongdan-gil ; Wonju-si Gangweondo, 26335 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
NTN M.I.ONE. CO.,LTD	Insight-IL	2019-12-19
LGX M.I.ONE. CO.,LTD	IC-3000	2019-12-19
FTT M.I.ONE. CO.,LTD	Insight-I	2019-12-19
FTT M.I.ONE. CO.,LTD	Insight-I+	2019-12-19
ETF M.I.ONE. CO.,LTD	IU-3000	2019-12-19
EPT M.I.ONE. CO.,LTD	Insight-u	2019-12-19
EPT M.I.ONE. CO.,LTD	Insight-u+	2019-12-19