Jiangsu Jianyu Health Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Jiangsu Jianyu Health Medical 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: 3009509445
• FEI Number: 3009509445
• Name: Jiangsu JianYu Health Medical Co., Ltd
• Owner & Operator: Jiangsu JianYu Health Medical Co., Ltd
• Contact Address: No.88 Longxi Avenue, Zhulin Town Jintan District; Changzhou City CN-32 Jiangsu 213241 CN
• Official Correspondent:
  • John Qui
  • 86-519-82445588-x
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Importing Logistics Registration:
  • Importer: Cardinal Health
  • Address: 700 Cardinal Place ; Dublin, OH 43017 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Zhixi Town Industry Zone ; Jintan City Jiangsu, 213251 CN
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3014926389
• FEI Number: 3014926389
• Name: Jiangsu JianYu Health Medical Co., Ltd
• Owner & Operator: Jiangsu JianYu Health Medical Co., Ltd
• Contact Address: No.88 Longxi Avenue, Zhulin Town Jintan District; Changzhou City CN-32 Jiangsu 213241 CN
• Official Correspondent:
  • John Qui
  • 86-519-82445588-x
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Importing Logistics Registration:
  • Importer: Cardinal Health
  • Address: 700 Cardinal Place ; Dublin, OH 43017 UNITED STATES
• Importing Logistics Registration:
  • Importer: PRIMA CARE MEDICAL SUPPLIES,INC
  • Address: 239 6TH AVE PATERSON NEW JERSEY, 7524 UNITED STATES ; Paterson, NJ 07524 UNITED STATES
• Importing Logistics Registration:
  • Importer: Welmed, Inc
  • Address: 691 N Lake St ; Grayslake, IL 60030 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No. 88 Longxi Avenue, Zhulin Town Jintan District; Changzhou City Jiangsu, 213241 CN
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Reprocess Single-Use Device

FDA Filings

Device Company	Device	Date
PMN K201754 Jiangsu JianYu Health Medical Co., Ltd.	JianYu Surgical Mask	2020-12-30
OEA Jiangsu JianYu Health Medical Co., Ltd	NON-SURGICAL ISOLATION GOWN	2020-04-17
PMN K100846 | FXX Jiangsu JianYu Health Medical Co., Ltd	SURGICAL FACE MASK	2020-04-13
LYU Jiangsu JianYu Health Medical Co., Ltd	ACCESSORY, SURGICAL APPAREL,	2020-03-26
HQY Jiangsu JianYu Health Medical Co., Ltd	MEDICAL ISOLATION GOGGLE, PROTECTIVE	2020-03-26
HOY Jiangsu JianYu Health Medical Co., Ltd	OPHTHALMIC MEDICAL ISOLATION GOGGLE	2020-03-26
KHA Jiangsu JianYu Health Medical Co., Ltd	Face Mask	2020-03-25
JOL Jiangsu JianYu Health Medical Co., Ltd	Yankauer; Suction Swab; Suction Toothbrush;Suction Handle ;Y-Connector;14FR Suction Catheter;	2019-12-11
JOL Jiangsu JianYu Health Medical Co., Ltd	Yankauer; Suction Swab; Suction Toothbrush;Suction Handle ;Y-Connector;14FR Suction Catheter;	2019-12-11
GCX Jiangsu JianYu Health Medical Co., Ltd	FLUID FIGHTER SUCTION MAT;SUCTION MAT;SUCTION RING; SUCTION RING WITH TUBING;	2019-12-11
GCX Jiangsu JianYu Health Medical Co., Ltd	FLUID FIGHTER SUCTION MAT;SUCTION MAT;SUCTION RING; SUCTION RING WITH TUBING;	2019-12-11
FOD Jiangsu JianYu Health Medical Co., Ltd	Sterile Umbilical cord clamp	2018-01-22
FOD Jiangsu JianYu Health Medical Co., Ltd	Sterile Umbilical cord clamp	2018-01-22
KNA Jiangsu JianYu Health Medical Co., Ltd	Amniotic Membrane Perforator	2017-08-18
FTA Jiangsu JianYu Health Medical Co., Ltd	Jianyu Health	2017-05-10
HFW Jiangsu JianYu Health Medical Co., Ltd	INTERNATIONAL MEDSURG CONNECTION	2017-03-24
LWK Jiangsu JianYu Health Medical Co., Ltd	Surgical Prep Razor	2013-07-14
LWH Jiangsu JianYu Health Medical Co., Ltd	Surgical, Sponge Stick and others	2013-07-14
JYH Jiangsu JianYu Health Medical Co., Ltd	Ear, nose and threat manual surgical instrument	2013-07-14
GEC Jiangsu JianYu Health Medical Co., Ltd	Brush, Scrub, Operating-Rooms	2013-07-14
FQM Jiangsu JianYu Health Medical Co., Ltd	Elastic Bandage	2013-07-14
GDY Jiangsu JianYu Health Medical Co., Ltd	Gauze/ Sponge, Internal X-Ray Detectable	2012-06-28
FRL Jiangsu JianYu Health Medical Co., Ltd	Medical Absorbent Fiber	2012-06-28
NAB Jiangsu JianYu Health Medical Co., Ltd	Nonresorable ( For External Use) Gauze/Sponge	2011-12-14
KXR Jiangsu JianYu Health Medical Co., Ltd	Resin Applicator	2011-12-14
JZE Jiangsu JianYu Health Medical Co., Ltd	Ear Spoon	2011-12-14
FXO Jiangsu JianYu Health Medical Co., Ltd	Surgical Suit	2011-12-14
FMK Jiangsu JianYu Health Medical Co., Ltd	Blood Lancet	2011-12-14
EHK Jiangsu JianYu Health Medical Co., Ltd	Prophylaxis Cup	2011-12-14