Taizhou Xinkang Medical Materials Co L T D

FDA Filings

This page includes the latest FDA filings for Taizhou Xinkang Medical Materials 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: 3005460813
• FEI Number: 3005460813
• Name: Fiona Chan
• Owner & Operator: Taizhou Xinkang Medical Materials Co., Ltd
• Contact Address: No. 18, Wuzhou (South) Road ; Taizhou CN-32 Jiangsu 225300 CN
• Official Correspondent:
  • Rujun Tang
  • 086-523-86848901-x
• US Agent:
  • Fiona Chan
  • SUNGO TECHNICAL SERVICE INC.
  • 855 9577779
  • sungo.group@yahoo.com
• Importing Logistics Registration:
  • Importer: DYNAREX CORP.
  • Address: 10 Glenshaw St. Orangeburg, NY 10962 ; Orangeburg, NY 10962 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6050 W Eastwood Ave Apt 201 ; Chicago, IL 60630 US
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06953102610711 Taizhou Xinkang Medical Materials Co., Ltd	OEM	2023-06-23
LRJ Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Povidone-iodine prep pad, Povidone-iodine swab stick	2020-03-14
LRJ Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Alcohol prep pad, Alcohol swab sticks, Antiseptic wipes, Normal saline wipe, Cleaning wipe, Soap wipe, BZK wipe;	2020-03-14
KXF Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	COTTON TIP APPLICATOR	2019-02-12
KXF Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	ABSORBENT TIP APPLICATOR	2019-02-12
IMD Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Instant ice pack, Instant cold pack, Instant hot pack	2019-02-12
HTD Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Plastic tweezers, plastic forceps	2019-02-12
KGB Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	CPR-Aid Rescuer Device, Single Use	2016-12-04
KHA Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	face mask, surgical mask, protective mask	2016-08-03
KHA Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Mouth to Mouth Mask	2016-08-03
HMP Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Eye Pad	2016-02-25
KNA Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Disposable Obstetrical Kit	2016-01-21
OHO Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	First Aid Kit	2015-08-26
FRL Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	non-sterile cotton ball, large 130pcs/bag, 10bags/cs	2014-07-31
EFN Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	non-sterile cotton roll, medium, dental 40/50/6/cs	2014-07-31
KME Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Emergency Blanket	2013-09-10
ILI Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Triangular Bandage	2013-09-10
FQM Fiona Chan [Taizhou Xinkang Medical Materials Co., Ltd]	Gauze Bandage	2013-09-10