Seegene Inc

FDA Filings

This page includes the latest FDA filings for Seegene Inc. 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)

096530

DUNS 688370667

FDA Registration(s)

• Registration Number: 3008937712
• FEI Number: 3008937712
• Name: Michael Smith
• Owner & Operator: Seegene Inc.
• Contact Address: Taewon Building 91, Ogeum-Ro; Songpa-gu KR-11 Seoul Teugbyeolsi 05548 KR
• Official Correspondent:
  • Jung-Woo Eo
  • 82-2-22405559-x
• US Agent:
  • Michael Smith
  • MDC Associates
  • 978 9273808
  • 866 5403448
  • regulatory@mdcassoc.com
• Importing Logistics Registration:
  • Importer: Seegene Technologies
  • Address: 325 North Wiget Lane Suite 140 ; Walnut Creek, CA 94598 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 180 Cabot St ; Beverly, MA 01915 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3013241946
• FEI Number: 3013241946
• Name: Seegene Technologies
• Owner & Operator: Seegene Inc.
• Contact Address: Taewon Building 91, Ogeum-Ro; Songpa-gu KR-11 Seoul Teugbyeolsi 05548 KR
• Official Correspondent:
  • Jung-Woo Eo
  • 82-2-22405559-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 325 North Wiget Lane Suite 140; Walnut Creek, CA 94598 US

FDA Filings

Device Company	Device	Date
GUDID 08809240109014 SEEGENE, INC.	Seegene NIMBUS 65415-03	2022-12-13
GUDID 08809240109007 SEEGENE, INC.	Seegene STARlet 67930-03	2022-12-13
GUDID 08809240000137 SEEGENE, INC.	STARMag 96 X 4 Viral DNA/RNA 200 C Kit EX00013C	2022-12-13
GUDID 08809240000069 SEEGENE, INC.	STARMag 96x4 Universal Plus Cartridge Kit EX00006C	2022-12-13
GUDID 08809240000007 SEEGENE, INC.	STARMag 96x4 Universal Cartridge Kit 744300.4.UC384	2022-12-13
JJH Michael Smith [Seegene Inc.]	Seegene STARlet	2019-05-28
JJH Michael Smith [Seegene Inc.]	Seegene NIMBUS	2019-05-28
JJH Michael Smith [Seegene Inc.]	STARMag 96x4 Universal Plus Cartridge Kit	2019-05-28
JJH Michael Smith [Seegene Inc.]	STARMag 96x4 Universal Cartridge Kit	2019-05-28

Related Finance Registrations

NCAGE Code	3L3H5	SEEGENE INC.
NCAGE Code	612BF	SEEGENE, INC.
CAGE Code	3L3H5	SEEGENE, INC.
CAGE Code	612BF	SEEGENE, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091868683	Pusan,South Korea -> Seattle, Washington	ARTICLES OF PLASTICS NIMBUS 96 DEEP WELL MIC	16 PKG