Intromedic Co L T D

FDA Filings

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

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

150840

DUNS 631065794

FDA Registration(s)

• Registration Number: 3007244127
• FEI Number: 3007244127
• Name: Minsung Kim
• Owner & Operator: IntroMedic Co., Ltd
• Contact Address: Suite 1105 1106 E&C Dream Tower 6 Cha Guro Dong, Guro Gu; Seoul KR-11 Seoul Teugbyeolsi 152-719 KR
• Official Correspondent:
  • Jinyoung Lee
  • 82-2-801-9300
• US Agent:
  • Minsung Kim
  • IntroMedic America Inc.
  • 929 2259154
  • diego@intromedic.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10671 Jefferwon ST NE ; Blaine, MN 55434 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3013684328
• FEI Number: 3013684328
• Name: IntroMedic Co., Ltd.
• Owner & Operator: IntroMedic Co., Ltd
• Contact Address: Suite 1105 1106 E&C Dream Tower 6 Cha Guro Dong, Guro Gu; Seoul KR-11 Seoul Teugbyeolsi 152-719 KR
• Official Correspondent:
  • Jinyoung Lee
  • 82-2-801-9300
• US Agent:
  • Minsung Kim
  • IntroMedic America Inc.
  • 929 2259154
  • diego@intromedic.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: F-RTEK 6F, 11-25, Simin-daero 327 beon-gil Dongan-gu; Anyang-si Gyeonggido, 14055 KR
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 18809260260587 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-09-17
GUDID 18809260260570 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-09-17
GUDID 18809260260563 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-09-17
GUDID 98809260260446 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-02-06
GUDID 18809260260358 IntroMedic Co., LTD.	MiroCam Capusle Endoscope System	2020-02-06
GUDID 08809260260498 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-02-06
GUDID 08809260260436 IntroMedic Co., LTD.	MiroCam Capusle Endoscope System	2020-02-06
GUDID 08809260260320 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-02-06
GUDID 08809260260290 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-02-06
GUDID 08809260260269 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-02-06
GUDID 08809260260191 IntroMedic Co., LTD.	MiroCam Capsule Endoscope System	2020-02-06
PMN K180732 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Software: MiroView U 4.0	2018-11-13
PMN K180732 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Receiver: MR2000	2018-11-13
PMN K180732 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule: MC1600-B	2018-11-13
PMN K180732 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2018-11-13
PMN K180732 | NEZ Minsung Kim [IntroMedic Co., Ltd]	Data Cable / Data Belt: MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)	2018-11-13
PMN K180732 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Software: MiroView U 4.0	2018-11-13
PMN K180732 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Receiver: MR2000	2018-11-13
PMN K180732 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule: MC1600-B	2018-11-13
PMN K180732 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2018-11-13
PMN K180732 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Data Cable / Data Belt: MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)	2018-11-13
PMN K180732 IntroMedic Co., Ltd.	MiroCam Capsule Endoscope System	2018-11-08
PMN K170438 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Software: MiroView U 4.0	2018-01-31
PMN K170438 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Receiver: MR2000	2018-01-31
PMN K170438 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule: MC2000-B	2018-01-31
PMN K170438 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2018-01-31
PMN K170438 | NEZ Minsung Kim [IntroMedic Co., Ltd]	Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)	2018-01-31
PMN K170438 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Software: MiroView U 4.0	2018-01-31
PMN K170438 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Receiver: MR2000	2018-01-31
PMN K170438 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule: MC2000-B	2018-01-31
PMN K170438 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2018-01-31
PMN K170438 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)	2018-01-31
PMN K170438 IntroMedic Co., Ltd.	MiroCam Capsule Endoscope System	2018-01-30
PMN K143663 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroView Software: MiroView U 3.0, MiroView RTV, MiroView RTV-i	2015-04-02
PMN K143663 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Receiver: MR1100	2015-04-02
PMN K143663 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule: MC1200-B	2015-04-02
PMN K143663 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2015-04-02
PMN K143663 | NEZ Minsung Kim [IntroMedic Co., Ltd]	Data Cable: MR1000-D	2015-04-02
PMN K143663 | NEZ Minsung Kim [IntroMedic Co., Ltd]	Data Belt: MR1000-D(S), MR1000-D(M), MR1000-D(L)	2015-04-02
PMN K143663 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroView Software: MiroView U 3.0, MiroView RTV, MiroView RTV-i	2015-04-02
PMN K143663 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Receiver: MR1100	2015-04-02
PMN K143663 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule: MC1200-B	2015-04-02
PMN K143663 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2015-04-02
PMN K143663 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Data Cable: MR1000-D	2015-04-02
PMN K143663 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Data Belt: MR1000-D(S), MR1000-D(M), MR1000-D(L)	2015-04-02
PMN K140751 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroView Software: MiroView U, MiroView RTV, MiroView RTV-i	2015-04-02
PMN K140751 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Receiver: MR1100	2015-04-02
PMN K140751 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule: MC1000-B	2015-04-02
PMN K140751 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2015-04-02
PMN K140751 | NEZ Minsung Kim [IntroMedic Co., Ltd]	Data Cable: MR1000-D	2015-04-02
PMN K140751 | NEZ Minsung Kim [IntroMedic Co., Ltd]	Data Belt: MR1000-D(M), MR1000-D(L)	2015-04-02
PMN K140751 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroView Software: MiroView U, MiroView RTV, MiroView RTV-i	2015-04-02
PMN K140751 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Receiver: MR1100	2015-04-02
PMN K140751 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule: MC1000-B	2015-04-02
PMN K140751 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2015-04-02
PMN K140751 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Data Cable: MR1000-D	2015-04-02
PMN K140751 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Data Belt: MR1000-D(M), MR1000-D(L)	2015-04-02
PMN K131131 | EOX Minsung Kim [IntroMedic Co., Ltd]	Processor: ER2000	2015-04-02
PMN K131131 | EOX Minsung Kim [IntroMedic Co., Ltd]	Probe: EP2000	2015-04-02
PMN K131131 | EOX Minsung Kim [IntroMedic Co., Ltd]	E.G. Scan II Esophagoscope System	2015-04-02
PMN K131131 | EOX Minsung Kim [IntroMedic Co., Ltd]	Controller: EC2000	2015-04-02
PMN K131131 | EOX IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Processor: ER2000	2015-04-02
PMN K131131 | EOX IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Probe: EP2000	2015-04-02
PMN K131131 | EOX IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	E.G. Scan II Esophagoscope System	2015-04-02
PMN K131131 | EOX IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Controller: EC2000	2015-04-02
PMN K143663 INTROMEDIC CO., LTD	MiroCam Capsule Endoscope System	2015-03-17
PMN K134005 INTROMEDIC CO., LTD	MIROCAM CAPSULE ENDOSCOPE SYSTEM	2014-07-09
PMN K140751 INTROMEDIC CO., LTD	MIROCAM CAPSULE ENDOSCOPE SYSTEM	2014-06-30
PMN K123428 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroView Software: MiroView U, MiroView RTV, MiroView RTVi	2013-07-22
PMN K123428 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Receiver: MR1100	2013-07-22
PMN K123428 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule: MC1000-B	2013-07-22
PMN K123428 | NEZ Minsung Kim [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2013-07-22
PMN K123428 | NEZ Minsung Kim [IntroMedic Co., Ltd]	Data CableL MR1000-D Data Belt: MR1000-D(M), MR1000-D(L)	2013-07-22
PMN K123428 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroView Software: MiroView U, MiroView RTV, MiroView RTVi	2013-07-22
PMN K123428 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Receiver: MR1100	2013-07-22
PMN K123428 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule: MC1000-B	2013-07-22
PMN K123428 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	MiroCam Capsule Endoscope System	2013-07-22
PMN K123428 | NEZ IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Data CableL MR1000-D Data Belt: MR1000-D(M), MR1000-D(L)	2013-07-22
PMN K131131 INTROMEDIC CO., LTD	E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM	2013-06-21
PMN K123428 INTROMEDIC CO., LTD	MIROCAM CAPSULE ENDOSCOPE SYSTEM	2013-05-20
PMN K120702 | EOX Minsung Kim [IntroMedic Co., Ltd]	Processor: ER2000	2012-09-27
PMN K120702 | EOX Minsung Kim [IntroMedic Co., Ltd]	Probe: EP2000	2012-09-27
PMN K120702 | EOX Minsung Kim [IntroMedic Co., Ltd]	E.G. Scan II Esophagoscope System	2012-09-27
PMN K120702 | EOX Minsung Kim [IntroMedic Co., Ltd]	Controller: EC2000	2012-09-27
PMN K120702 | EOX IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Processor: ER2000	2012-09-27
PMN K120702 | EOX IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Probe: EP2000	2012-09-27
PMN K120702 | EOX IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	E.G. Scan II Esophagoscope System	2012-09-27
PMN K120702 | EOX IntroMedic Co., Ltd. [IntroMedic Co., Ltd]	Controller: EC2000	2012-09-27
PMN K120702 INTROMEDIC CO., LTD	E.G. SCAN II ESPHAGOSCOPE SYSTEM	2012-06-20
PMN K111450 INTROMEDIC CO., LTD	MIROCAM CAPSULE ENDOSCOPE SYSTEM	2012-05-18
PMN K111030 INTROMEDIC CO., LTD	E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM	2011-10-21