Suzhou Herui Biomed Co L T D

FDA Filings

This page includes the latest FDA filings for Suzhou Herui Biomed 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: 0
• FEI Number: 0
• Name: XIAOBING YU
• Owner & Operator: Suzhou Herui BioMed Co. ,Ltd
• Contact Address: Room 310/312/313, Floor B2, Bi ological ; SUZHOU CN-32 Jiangsu 215000 CN
• Official Correspondent:
  • TING YAO
  • 86-0512-80963713-x
• US Agent:
  • XIAOBING YU
  • 240 4980502
  • china@sophisters.com
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 781 Coronada Ln Foster City; Foster City, CA 94404 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GIF XIAOBING YU [Suzhou Herui BioMed Co. ,Ltd]	Herui BioMed Sample Diluent special for COVID-19 Testing kit	2020-04-09
PMN K192123 | LCX XIAOBING YU [Suzhou Herui BioMed Co. ,Ltd]	Herui BioMed Novel Coronavirus (2019-nCoV ) IgG/IgM Antibody Detection Kit	2020-04-04
GNH XIAOBING YU [Suzhou Herui BioMed Co. ,Ltd]	Novel Coronavirus (2019-nCoV ) IgG/IgM Antibody Detection Kit	2020-04-04