Cg Bio Co L T D

FDA Filings

This page includes the latest FDA filings for Cg Bio 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: 3016246057
• FEI Number: 3016246057
• Name: SHANE LIU
• Owner & Operator: CG Bio Co., Ltd.
• Contact Address: 244, Galmachi-ro, Jungwon-gu, ; Seongnam-si KR-41 Gyeonggido 13211 KR
• Official Correspondent:
  • Chanmin Ahn
  • 82-31-7360541-x
• US Agent:
  • SHANE LIU
  • CALWAYS INTERNATIONAL, LLC
  • 408 6769063
  • fda4u@126.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: CAMPBELL, CALIFORNIA, 95008, UNITED STATES ; Campbell, CA 95008 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3008679610
• FEI Number: 3006724198
• Name: CG BIO CO., LTD.
• Owner & Operator: CG Bio Co., Ltd.
• Contact Address: 244, Galmachi-ro, Jungwon-gu, ; Seongnam-si KR-41 Gyeonggido 13211 KR
• Official Correspondent:
  • Chanmin Ahn
  • 82-31-7360541-x
• US Agent:
  • Shane Liu
  • Calways International, LLC
  • 408 6769063
  • fda4u@126.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 244, Galmachi-ro, Jungwon-gu, ; Seongnam-si Gyeonggido, 13211 KR
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 08809429616364 CG Bio Co., Ltd.	LumFix spinal fixation system	2021-02-11
GUDID 08809658605566 CG Bio Co., Ltd.	LumFix spinal fixation system	2020-08-04
GUDID 08809304756819 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2020-07-29
GUDID 08809429614858 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-12-10
LXH SHANE LIU [CG Bio Co., Ltd.]	Reusable Surgical Instrument	2019-11-22
GUDID 08809550978768 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-11-07
GUDID 08809429619341 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619334 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619327 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619310 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619303 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619242 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619235 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619228 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619211 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619204 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619129 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619112 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809429619105 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809304757687 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-28
GUDID 08809658602039 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658602022 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658602015 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658602008 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601995 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601988 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601971 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601964 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601957 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601940 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601933 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601926 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601919 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601902 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601896 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601889 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601872 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601865 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601858 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601841 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601834 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601827 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601810 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809658601803 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809550978461 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429619099 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429618757 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429618740 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429618733 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429614872 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429614841 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429614834 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429611130 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429611031 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429611024 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429611017 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809429610904 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809304757007 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809304756994 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
GUDID 08809304756987 CG Bio Co., Ltd.	LumFix Spinal Fixation System	2019-10-25
JQC SHANE LIU [CG Bio Co., Ltd.]	MD416, CGBMC Kit	2019-03-07
JQC SHANE LIU [CG Bio Co., Ltd.]	Centrifuge (MD416) + Concentration Kit (CGBMC)	2019-03-07
PMN K160731 | MNI CG BIO CO., LTD.	LumFix Spinal Fixation System	2016-11-14
PMN K160731 | MNH CG BIO CO., LTD.	LumFix Spinal Fixation System	2016-11-14
PMN K160731 CG BIO CO., LTD.	LumFix Spinal Fixation Sytem	2016-10-04
MDA CG BIO CO., LTD.	Scarsense stick	2016-02-11
PMN K122490 | OMP SHANE LIU [CG Bio Co., Ltd.]	KulaVAC	2014-04-18
NAC CG BIO CO., LTD.	Easyfoam	2012-06-07
NAC CG BIO CO., LTD.	Easyderm thin	2012-06-07
NAC CG BIO CO., LTD.	Easyderm plus	2012-06-07
NAC CG BIO CO., LTD.	Easyderm plus thin	2012-06-07
NAC CG BIO CO., LTD.	Easyderm foam	2012-06-07
NAC CG BIO CO., LTD.	Easyderm beauty	2012-06-07

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• CGBIO CO., LTD