Hunan Derom Biomedical Engineering Co L T D

FDA Filings

This page includes the latest FDA filings for Hunan Derom Biomedical Engineering 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: Fiona Chan
• Owner & Operator: Hunan DEROM Biomedical Engineering Co., Ltd.
• Contact Address: 301-12, 401-2, Building 17, Shanhe Pharm Shaping Street, Kaifu District; Changsha CN-43 Hunan 410153 CN
• Official Correspondent:
  • Dong Li
  • 86-731-8698-3616
• US Agent:
  • Fiona Chan
  • SUNGO Technical Service Inc.
  • 855 9577779
  • US.FDA@sungogroup.com
• Registration Status: 5
• 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

FDA Filings

Device Company	Device	Date
QKR Fiona Chan [Hunan DEROM Biomedical Engineering Co., Ltd.]	Single-use medical face mask	2020-03-28
LYU Fiona Chan [Hunan DEROM Biomedical Engineering Co., Ltd.]	Single-use medical face mask	2020-03-28