Biohit Healthcare Hefei Co L T D

FDA Filings

This page includes the latest FDA filings for Biohit Healthcare Hefei 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: BIOHIT HEALTHCARE (HEFEI) CO., LTD.
• Owner & Operator: Biohit Healthcare (Hefei) Co., Ltd.
• Official Correspondent:
  • Linda Wang
  • 86-0551-68561563-x
• US Agent:
  • Wen Wang
  • Willow Glen Consultancy LLC
  • 619 8690249
  • Wen.Wang@WillowGlenFDA.com
• Importing Logistics Registration:
  • Importer: Willow Glen Consultancy LLC
  • Address: 3755 Avocado Blvd, #208 ; La Mesa, CA 91941 UNITED STATES
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Building D9, Innovation Park, West Wangjiang Road No.800, High-T ; Hefei Anhui, 230088 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06973774259803 Biohit Healthcare (Hefei) Co., Ltd.	Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit REF:207.01.25.02	2022-10-17
GUDID 16973774250012 Biohit Healthcare (Hefei) Co., Ltd.	Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit REF:207.01.25.02	2022-08-24
QKO BIOHIT HEALTHCARE (HEFEI) CO., LTD.	SARS-CoV-2 IgM/IgG Antibody Test kit (Colloidal Gold Method)	2020-04-16
KHA BIOHIT HEALTHCARE (HEFEI) CO., LTD.	Biohit Healthcare (Hefei)	2020-04-14