Zhanjiang Star Enterprise Co L T D

FDA Filings

This page includes the latest FDA filings for Zhanjiang Star Enterprise 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: 3014101089
• FEI Number: 3014101089
• Name: Yang LingYun
• Owner & Operator: Zhanjiang Star Enterprise Co.,Ltd
• Contact Address: NO.1, West Jinhua Road, Mazhang District ; Zhanjiang CN-44 Guangdong 524094 CN
• Official Correspondent:
  • Hetian San
  • 86-759-3306679-x
• US Agent:
  • Yang LingYun
  • 919 4751044
  • usagency@126.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 605 Sherwood Forest Place, Cary, North Carolina ; Cary, NC 27519 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
EYI Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	External catheter, Silicone external catheter, Size 40mm(XXL), 35mm(XL), 30mm(L), 25mm(M), 20mm(S)	2018-01-30
EYI Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	External catheter, Latex external catheter, Size 40mm(XXL), 35mm(XL), 30mm(L), 25mm(M), 20mm(S)	2018-01-30
PMN K170234 | BTR Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Uncuffed Reinforced Endotracheal tube,Size(I.D)3.0,3.5,4.0,4.5,5.0,5.5,6.0,6.5,7.0,7.5,8.0,8.5,9.0	2018-01-29
PMN K170234 | BTR Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Uncuffed Endotracheal tube, Size(I.D)2.5,3.0,3.5,4.0,4.5,5.0,5.5,6.0,6.5,7.0,7.5,8.0,8.5,9.0,9.5,10.0	2018-01-29
PMN K170234 | BTR Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Cuffed Reinforced Endotracheal tube, Size(I.D)3.0,3.5,4.0,4.5,5.0,5.5,6.0,6.5,7.0,7.5,8.0,8.5,9.0	2018-01-29
PMN K170234 | BTR Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Cuffed Endotracheal tube, Size(I.D):2.5,3.0,3.5,4.0,4.5,5.0,5.5,6.0,6.5,7.0,7.5,8.0,8.5,9.0,9.5,10.0	2018-01-29
PMN K170234 Zhanjiang Star Enterprise Co., Ltd	Endotracheal Tube; Reinforced Endotracheal Tube	2018-01-17
PMN K170233 | EZL Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Disposable Urinary Catheter, Silicone Urinary Catheter, Nelaton type,Two way type and Three way type,From 8 Fr to 24 Fr	2017-11-03
PMN K170233 | EZL Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Disposable Urinary Catheter, PVC Urinary Catheter, Nelaton type From 8 Fr to 20 Fr	2017-11-03
PMN K170233 | EZL Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Disposable Urinary Catheter, Latex Urinary Catheter, Nelaton type,Two way type and Three way type, From 8 Fr to 24 Fr	2017-11-03
PMN K170233 | EZD Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Disposable Urinary Catheter, Silicone Urinary Catheter, Nelaton type,Two way type and Three way type,From 8 Fr to 24 Fr	2017-11-03
PMN K170233 | EZD Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Disposable Urinary Catheter, PVC Urinary Catheter, Nelaton type From 8 Fr to 20 Fr	2017-11-03
PMN K170233 | EZD Yang LingYun [Zhanjiang Star Enterprise Co.,Ltd]	Disposable Urinary Catheter, Latex Urinary Catheter, Nelaton type,Two way type and Three way type, From 8 Fr to 24 Fr	2017-11-03
PMN K170233 Zhanjiang Star Enterprise Co., Ltd	Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)	2017-10-13

Related Finance Registrations

NCAGE Code	SBHM1	ZHANJIANG STAR ENTERPRISE CO.,LTD
CAGE Code	SBHM1	ZHANJIANG STAR ENTERPRISE CO.,LTD