Tae Chang Industrial Co L T D

FDA Filings

This page includes the latest FDA filings for Tae Chang Industrial 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: 3011676762
• FEI Number: 3011676762
• Name: Tae-Chang Industrial Co., Ltd.
• Owner & Operator: Tae-Chang Industrial Co., Ltd.
• Contact Address: 8-18, Bojeokdong-gil, Useong-myeon ; Gongju-si KR-44 Chungcheongnamdo 32533 KR
• Official Correspondent:
  • Jung-ryun In
  • 82-41-8547422-x
• US Agent:
  • Priscilla Chung
  • LK Consulting Group USA, Inc.
  • 714 2025789
  • juhee.c@lkconsultinggroup.com
• Importing Logistics Registration:
  • Importer: MEDIBIO USA LLC
  • Address: 4846 Citrus Way ; Cooper City, FL 33330 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 127, Sanho-daero ; Gumi-si Gyeongsangbugdo, 39378 KR
• Establishment Type:
  • Manufacture Medical Device
  • Sterilize Medical Device for Another Party (Contract Sterilizer)
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3004504731
• FEI Number: 3004504731
• Name: Priscilla Chung
• Owner & Operator: Tae-Chang Industrial Co., Ltd.
• Contact Address: 8-18, Bojeokdong-gil, Useong-myeon ; Gongju-si KR-44 Chungcheongnamdo 32533 KR
• Official Correspondent:
  • Jung-ryun In
  • 82-41-8547422-x
• US Agent:
  • Priscilla Chung
  • LK Consulting Group USA, Inc.
  • 714 2025789
  • juhee.c@lkconsultinggroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1150 ROOSEVELT, SUITE 200 ; Irvine, CA 92620 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K180720 | FMI Tae-Chang Industrial Co., Ltd.	True plus	2019-02-27
PMN K180720 | FMI Tae-Chang Industrial Co., Ltd.	True plus Quinta tip	2019-02-27
PMN K180720 | FMI Tae-Chang Industrial Co., Ltd.	Trividia health	2019-02-27
PMN K180720 | FMI Tae-Chang Industrial Co., Ltd.	Medifine Pen Needle Quinta 5 Bevel	2019-02-27
PMN K180720 | FMI Tae-Chang Industrial Co., Ltd.	Medifine Pen Needle 3 Bevel	2019-02-27
PMN K180720 | FMI Tae-Chang Industrial Co., Ltd.	Insuflo	2019-02-27
PMN K180720 | FMI Tae-Chang Industrial Co., Ltd.	Insuflo Quinta	2019-02-27
PMN K171144 | FMI Tae-Chang Industrial Co., Ltd.	True plus	2017-11-17
PMN K171144 | FMI Tae-Chang Industrial Co., Ltd.	True plus Quinta tip	2017-11-17
PMN K171144 | FMI Tae-Chang Industrial Co., Ltd.	Trividia health	2017-11-17
PMN K171144 | FMI Tae-Chang Industrial Co., Ltd.	Medifine Pen Needle Quinta 5 Bevel	2017-11-17
PMN K171144 | FMI Tae-Chang Industrial Co., Ltd.	Medifine Pen Needle 3 Bevel	2017-11-17
PMN K171144 | FMI Tae-Chang Industrial Co., Ltd.	Insuflo	2017-11-17
PMN K171144 | FMI Tae-Chang Industrial Co., Ltd.	Insuflo Quinta	2017-11-17
PMN K983858 | MIA Priscilla Chung [Tae-Chang Industrial Co., Ltd.]	Portex Spinal Needles	2016-08-29
PMN K133100 | FMI Tae-Chang Industrial Co., Ltd.	CAREFINE PEN NEEDLE	2014-03-17
PMN K895771 | FMI Tae-Chang Industrial Co., Ltd.	Exel Spinal Needles	2008-02-05
PMN K895771 | FMI Priscilla Chung [Tae-Chang Industrial Co., Ltd.]	Exel Spinal Needles	2008-02-05