Genoray Co L T D

FDA Filings

This page includes the latest FDA filings for Genoray Co L T D. 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)

122310

DUNS 631064672

FDA Registration(s)

• Registration Number: 3005843418
• FEI Number: 3005843418
• Name: GENORAY CO., LTD.
• Owner & Operator: GENORAY CO., LTD.
• Contact Address: 512, 560, Dunchon-daero, Jungwon-gu, Seo Gyeonggi-do, Korea; SEONGNAM KR-NOTA 13230 KR
• Official Correspondent:
  • BYUNG-UK - PARK
  • 82-31-7404198-x
• US Agent:
  • Kaitlynn Min
  • Genoray America Inc.
  • 855 4366729 223
  • 714 7868919
  • kaitlynn@genorayamerica.com
• Importing Logistics Registration:
  • Importer: GENORAY America Inc.
  • Address: 1073 N. Batavia St ; Orange, CA 92867 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 512, 560, Dunchon-daero, Jungwon-gu ; Seongnam-city Gyeonggido, 462-716 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08809244069055 GENORAY CO., LTD.	Genoray	2023-12-22
GUDID 08809244069048 GENORAY CO., LTD.	Genoray	2023-12-22
GUDID 08809244061240 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061233 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061226 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061202 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061196 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061189 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061172 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061165 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061141 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244061035 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244060113 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244060106 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244060083 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244060021 GENORAY CO., LTD.	Genoray	2023-12-08
GUDID 08809244060458 Genoray Co., Ltd.	Genoray	2023-11-27
GUDID 08809244060076 Genoray Co., Ltd.	Genoray	2023-10-03
GUDID 08809244060069 Genoray Co., Ltd.	Genoray	2023-08-07
GUDID 08809244061219 Genoray Co., Ltd.	Genoray	2023-07-28
GUDID 08809244061097 Genoray Co., Ltd.	Genoray	2023-06-26
GUDID 08809244061080 Genoray Co., Ltd.	Genoray	2023-06-26
GUDID 08809244061066 Genoray Co., Ltd.	Genoray	2023-06-26
GUDID 08809244060144 Genoray Co., Ltd.	Genoray	2023-06-22
GUDID 08809244060137 Genoray Co., Ltd.	Genoray	2023-06-22
GUDID 08809244061134 Genoray Co., Ltd.	Genoray	2022-05-27
GUDID 08809244061127 Genoray Co., Ltd.	Genoray	2022-05-27
GUDID 08809244061110 Genoray Co., Ltd.	Genoray	2022-05-27
GUDID 08809244061103 Genoray Co., Ltd.	Genoray	2022-05-27
PMN K220423 GENORAY Co., Ltd.	PAPAYA & PAPAYA Plus	2022-05-19
PMN K220392 GENORAY Co., Ltd.	PAPAYA 3D & PAPAYA 3D Plus	2022-05-19
GUDID 08809244060120 Genoray Co., Ltd.	Genoray	2022-03-30
PMN K211780 Genoray Co., Ltd.	ZEN-2090 Turbo	2022-03-09
PMN K200469 Genoray Co.,Ltd	PAPAYA 3D Premium & PAPAYA 3D Premium Plus	2020-09-16
PMN K181943 | OWB GENORAY CO., LTD.	OSCAR (OSCAR Prime, OSCAR Classic)	2018-08-20
PMN K181943 | JAA GENORAY CO., LTD.	OSCAR (OSCAR Prime, OSCAR Classic)	2018-08-20
PMN K181943 Genoray Co., Ltd.	OSCAR (OSCAR Prime, OSCAR Classic)	2018-08-17
PMN K172810 | EHD GENORAY CO., LTD.	ZEN-PX4	2018-04-02
PMN K172810 | EHD GENORAY CO., LTD.	PORT-X IV	2018-04-02
PMN K172180 | OWB GENORAY CO., LTD.	OSCAR 15	2018-04-02
PMN K172180 | JAA GENORAY CO., LTD.	OSCAR 15	2018-04-02
PMN K172810 GENORAY Co., Ltd.	PORT-X IV	2018-03-07
PMN K172180 Genoray Co.,Ltd	OSCAR 15	2018-02-09
PMN K150354 | OAS GENORAY CO., LTD.	Suni Q3D	2015-12-15
PMN K150354 | OAS GENORAY CO., LTD.	Suni Q-C3D	2015-12-15
PMN K150354 | OAS GENORAY CO., LTD.	PAPAYA 3D Plus	2015-12-15
PMN K150354 | MUH GENORAY CO., LTD.	Suni Q3D	2015-12-15
PMN K150354 | MUH GENORAY CO., LTD.	Suni Q-C3D	2015-12-15
PMN K150354 | MUH GENORAY CO., LTD.	PAPAYA 3D Plus	2015-12-15
PMN K150354 GENORAY CO., LTD.	PAPAYA 3D Plus	2015-12-10
PMN K140041 | OXO GENORAY CO., LTD.	ZEN-7000	2014-12-01
PMN K140041 | OWB GENORAY CO., LTD.	ZEN-7000	2014-12-01
PMN K140041 | JAA GENORAY CO., LTD.	ZEN-7000	2014-12-01
PMN K140041 GENORAY CO., LTD.	ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM	2014-11-28
PMN K141700 | MUH GENORAY CO., LTD.	SUNI Pan Q	2014-11-10
PMN K141700 | MUH GENORAY CO., LTD.	SUNI Pan Q-C	2014-11-10
PMN K141700 | MUH GENORAY CO., LTD.	PAPAYA	2014-11-10
PMN K141700 | MUH GENORAY CO., LTD.	PAPAYA Plus	2014-11-10
PMN K141700 GENORAY CO., LTD.	PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	2014-10-31
PMN K130419 | MUH GENORAY CO., LTD.	PAPAYA	2013-11-10
PMN K130419 | MUH GENORAY CO., LTD.	PAPAYA Plus	2013-11-10
PMN K130419 GENORAY CO., LTD.	PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	2013-11-06
PMN K130088 | MUH GENORAY CO., LTD.	PortView	2013-07-22
PMN K130088 GENORAY CO., LTD.	PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM	2013-07-18
PMN K120263 | OAS GENORAY CO., LTD.	VOLUX 21C	2012-07-12
PMN K120263 | OAS GENORAY CO., LTD.	VOLUX 21	2012-07-12
PMN K120263 | MUH GENORAY CO., LTD.	VOLUX 21C	2012-07-12
PMN K120263 | MUH GENORAY CO., LTD.	VOLUX 21	2012-07-12
PMN K120263 GENORAY CO., LTD.	VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	2012-07-10
PMN K103181 | LLZ GENORAY CO., LTD.	Zenis	2011-11-16
PMN K103181 GENORAY CO., LTD.	ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	2011-08-26
PMN K103182 | LLZ GENORAY CO., LTD.	Triana	2011-01-25
PMN K103182 GENORAY CO., LTD.	TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	2011-01-14
PMN K092171 | MUH GENORAY CO., LTD.	VOLUX	2010-05-10
PMN K092171 GENORAY CO., LTD.	VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	2010-04-26
PMN K091918 | OXO GENORAY CO., LTD.	ZEN-2090 Pro	2009-11-17
PMN K091918 | OWB GENORAY CO., LTD.	ZEN-2090 Pro	2009-11-17
PMN K091918 | JAA GENORAY CO., LTD.	ZEN-2090 Pro	2009-11-17
PMN K091918 GENORAY CO., LTD.	ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO	2009-10-07
PMN K063121 | EHD GENORAY CO., LTD.	ZEN-PX2	2007-04-03
PMN K063121 | EHD GENORAY CO., LTD.	PORT-X II	2007-04-03
PMN K063121 GENORAY CO., LTD.	PORTABLE X-RAY SYSTEM, MODEL PORT-X II	2007-01-11

Related Finance Registrations

NCAGE Code	1U59F	GENORAY CO.,LTD
CAGE Code	1U59F	GENORAY CO.,LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092251932	Pusan,South Korea -> Long Beach, California	DIGITAL PANORAMIC &CBCT X-RAY SYSTEM 9022.12	13 PKG
2020081264153	Pusan,South Korea -> Long Beach, California	DIGITAL PANORAMIC & CBCT X-RAY SYSTEM	17 CTN
2020072770266	Pusan,South Korea -> Long Beach, California	DIGITAL PANORAMIC & CEPHALOMETRIC X-RAY SYSTE M	16 CTN
2020041732577	Pusan,South Korea -> Long Beach, California	C-ARM X-RAY SYSTEM	40 CTN
2020040633030	Pusan,South Korea -> Los Angeles, California	C-ARM X-RAY SYSTEM	10 CTN
2020030942077	Pusan,South Korea -> Long Beach, California	C-ARM X-RAY SYSTEM	26 CTN
2020020853977	Pusan,South Korea -> Los Angeles, California	C-ARM X-RAY SYSTEM	8 CTN
2020013151973	Pusan,South Korea -> Los Angeles, California	C-ARM X-RAY SYSTEM	9 PKG