Newscen Coast Bio Pharmaceutical Co L T D

FDA Filings

This page includes the latest FDA filings for Newscen Coast Bio Pharmaceutical 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: 3006109338
• FEI Number: 3006109338
• Name: Chiao-ih Hui
• Owner & Operator: NewScen Coast Bio-Pharmaceutical Co., Ltd.
• Contact Address: No 65 6th Street, TEDA ; Tianjin CN-12 Tianjin 300457 CN
• Official Correspondent:
  • Hua-Ing Wei
  • 86-22-25321648-817
• US Agent:
  • Chiao-ih Hui
  • Medsential
  • 844 8467871
  • chiaoih@medsential.com
• Importing Logistics Registration:
  • Importer: Medsential
  • Address: 1136 South 3600West ; Salt Lake City, UT 84104 UNITED STATES
  • Phone: 1 801 8796658
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1136 South 3600West ; Salt Lake City, UT 84104 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QKO Chiao-ih Hui [NewScen Coast Bio-Pharmaceutical Co., Ltd.]	Covid-19 IgG/IgM Rapid Test Cassette	2020-03-31
PMN K112315 | JHI Chiao-ih Hui [NewScen Coast Bio-Pharmaceutical Co., Ltd.]	Visual, Pregnancy Hcg, Prescription Use	2020-03-27
PMN K112315 NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD	HOME PREGNANCY TEST	2012-04-23