I Sens Wonju Factory 2

FDA Filings

This page includes the latest FDA filings for I Sens Wonju Factory 2. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015168139
• FEI Number: 3015168139
• Name: i-SENS Wonju Factory 2
• Owner & Operator: i-SENS, Inc.
• Contact Address: 43, Banpo-daero 28-gil, Seocho-gu ; Seoul KR-11 Seoul Teugbyeolsi 06646 KR
• Official Correspondent:
  • Hyun Joon Oh
  • 82-2-9166191-x
• US Agent:
  • Jeonghan Ha
  • i-SENS USA, Inc.
  • 310 3200254
  • i-sens-usa@i-sens.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 200, Gieopdosi-ro, Jijeong-myeon ; Wonju-si Gangweondo, 26354 KR
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K192859 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	CareSens S Clear BT Blood Glucose Monitoring System	2020-01-25
PMN K193590 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	CareSens S Fit BT Blood Glucose Monitoring System	2020-01-19
PMN K192220 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	ReliOn Premier Classic Blood Glucose Monitoring System	2019-12-15
PMN K181273 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	GLUCOCARD Shine Express Blood Glucose Monitoring System	2018-11-01
PMN K181273 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	GLUCOCARD Shine Connex Blood Glucose Monitoring System	2018-11-01
PMN K170463 | JIN i-SENS Wonju Factory 2 [i-SENS, Inc.]	KetoSens Multi Blood ?-Ketone Monitoring System	2018-04-15
PMN K170463 | JIN i-SENS Wonju Factory 2 [i-SENS, Inc.]	KetoSens Blood ?-Ketone Monitoring System	2018-04-15
PMN K171480 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	NoCoding1 Plus Blood Glucose Monitoring System	2017-12-13
PMN K171480 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	CareSens N Plus BT Blood Glucose Monitoring System	2017-12-13
PMN K160742 | NBW i-SENS Wonju Factory 2 [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | JJX i-SENS Wonju Factory 2 [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02
PMN K160742 | CGA i-SENS Wonju Factory 2 [i-SENS, Inc.]	VeraSens Blood Glucose Monitoring System	2017-02-02