Kogenebiotech Co L T D

FDA Filings

This page includes the latest FDA filings for Kogenebiotech 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: Michael van der Woude
• Owner & Operator: KogeneBiotech Co., Ltd.
• Contact Address: C 1101, 168 Gasan Digital 1ro, Geumcheon ; Seoul KR-11 Seoul Teugbyeolsi 08507 KR
• Official Correspondent:
  • Myoah BAEK
  • 82-22-0262150-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road, Bldg 1, Suite 300 ; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QJR Michael van der Woude [KogeneBiotech Co., Ltd.]	PowerChekTM 2019-nCoV Real-time PCR Kit	2020-04-08