Sunwell Biotech Co L T D

FDA Filings

This page includes the latest FDA filings for Sunwell Biotech 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: 3009663347
• FEI Number: 3009663347
• Name: SUNWELL BIOTECH CO., LTD.
• Owner & Operator: Sunwell Biotech Co., Ltd.
• Contact Address: No.9,Yongxing Road Gangzha Economic Development Zone; Nantong City CN-32 Jiangsu 226000 CN
• US Agent:
  • Charles Mack
  • IRC USA
  • 931 6254938
  • 541 3765063
  • ircfda@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No.9,Yongxing Road Gangzha Economic Development Zone; Nantong City Jiangsu, 226000 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
MSH SUNWELL BIOTECH CO., LTD.	N95 Protective Mask	2020-03-25
PMN K170002 | JKA SUNWELL BIOTECH CO., LTD.	Blood Collection Sets	2017-12-26
PMN K170002 | FPA SUNWELL BIOTECH CO., LTD.	Blood Collection Sets	2017-12-26
PMN K121637 | MEG SUNWELL BIOTECH CO., LTD.	Auto-Disable Sterile Safety Syringe for Single Use, 0.5 ml,1 ml,2 ml,2.5 ml,3 ml,5 ml,10 ml	2012-11-12
PMN K121637 SUNWELL BIOTECH CO., LTD	AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE	2012-10-25