Bioneer Corp

FDA Filings

This page includes the latest FDA filings for Bioneer Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

064550

DUNS 688014216

Bioneer Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• BIONEER CORPORATION

FDA Registration(s)

• Registration Number: 3010049938
• FEI Number: 3010049938
• Name: BIONEER CORPORATION
• Owner & Operator: Bioneer Inc.
• Contact Address: 155 Filbert St. Suite 216 ; Oakland CA 94607 US
• Official Correspondent:
  • Myeong H Kim
  • 1-877-2644300-x
• US Agent:
  • Edgar Elenes
  • BIONEER, INC.
  • 877 2644300
  • 510 8650350
  • edgar.elenes@bioneer.us.com
• Importing Logistics Registration:
  • Importer: Bioneer Corporation
  • Address: 8-11, Munpyeongseo-ro ; Daedeok-gu, 306-220 KOREA, REPUBLIC OF
  • Importer Type: Manufacturer
  • Subdivision: KR-30
• Importing Logistics Registration:
  • Importer: BIONEER, INC.
  • Address: 1000 ATLANTIC AVE STE 102 ; Alameda, CA 94501 UNITED STATES
  • Email Address: mhkim@bioneer.us.com
  • Phone: 1 510 8650330
  • FAX: 1 510 8650350
  • Importer Type: RETAILER
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8-11, Munpyeongseo-ro ; Daedeok-gu Daejeon Gwangyeogsi, 34302 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08809537078443 Bioneer Corporation	Exicycler™ V5 384 Fast	2024-09-17
GUDID 08809537078436 Bioneer Corporation	Exicycler™ V5 384	2024-09-17
GUDID 08809537078429 Bioneer Corporation	Exicycler™ V5 96 Fast	2024-09-17
GUDID 08809537078412 Bioneer Corporation	Exicycler™ V5 96	2024-09-17
GUDID 08809537077750 Bioneer Corporation	ExiPrep™16 Plus	2022-09-12
GUDID 08809537070461 Bioneer Corporation	Protonion™ 96 Viral RNA Kit K-4731	2022-09-12
GUDID 08809537070188 Bioneer Corporation	ExiPrep™96 Lite	2022-09-12
GUDID 08809537070065 Bioneer Corporation	ExiPrep™16 Dx	2022-09-12
GUDID 08809537070058 Bioneer Corporation	ExiPrep™48 Dx	2022-09-12
GUDID 08809357179870 Bioneer Corporation	ExiPrep™ 96 Genomic DNA Kit K-4611	2022-09-12
GUDID 08809357179498 Bioneer Corporation	MagListo™ 5M Viral DNA/RNA Extraction Kit K-3617	2022-09-12
GUDID 08809357179481 Bioneer Corporation	ExiPrep™ 96 Viral DNA/RNA Kit K-4614	2022-09-12
GUDID 08809357178316 Bioneer Corporation	ExiPrep™ 48 Viral RNA Kit K-4573	2022-09-12
GUDID 08809357178309 Bioneer Corporation	ExiPrep™ 48 Viral DNA/RNA Kit K-4571	2022-09-12
GUDID 08809357174233 Bioneer Corporation	ExiPrep™ Dx Mycobacteria Genomic DNA Kit K-4418	2022-09-12
GUDID 08809357174219 Bioneer Corporation	ExiPrep™ Dx Bacteria Genomic DNA Kit K-4414	2022-09-12
GUDID 08809357174196 Bioneer Corporation	ExiPrep™ Dx Blood Genomic DNA Kit K-4411	2022-09-12
GUDID 08809357174172 Bioneer Corporation	ExiPrep™ Dx Viral DNA Kit K-4472	2022-09-12
GUDID 08809357174158 Bioneer Corporation	ExiPrep™ Dx Viral DNA/RNA Kit K-4471	2022-09-12
GUDID 08809357174134 Bioneer Corporation	ExiPrep™ Dx Viral RNA Kit K-4473	2022-09-12
GUDID 08809537070751 Bioneer Corporation	Exicycler™ 384 A-2061	2021-07-30
GUDID 08809537070034 Bioneer Corporation	Exicycler™ 96 A-2060-1	2021-07-30
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Viral RNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Viral DNA/RNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Viral DNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Mycobacteria genomic DNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Blood Genomic DNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep Dx Bacteria Genomic DNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 96 Viral DNA/RNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 48 Viral RNA Kit	2017-08-23
PPM BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 48 Viral DNA/RNA Kit	2017-08-23
JJH BIONEER CORPORATION [Bioneer Inc.]	ExiPrep48 Dx	2010-12-06
JJH BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 96 Lite	2010-12-06
JJH BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 16 Plus	2010-12-06
JJH BIONEER CORPORATION [Bioneer Inc.]	ExiPrep 16 Dx	2010-12-06

Related Finance Registrations

NCAGE Code	2V56F	BIONEER CORPORATION
NCAGE Code	7803F	BIONEER CORPORATION
CAGE Code	2V56F	BIONEER CORPORATION
CAGE Code	7803F	BIONEER CORPORATION