Ellex Medical Pty L T D

FDA Filings

This page includes the latest FDA filings for Ellex Medical Pty 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: 3005641545
• FEI Number: 3005641545
• Name: ELLEX ISCIENCE INC.
• Owner & Operator: ELLEX MEDICAL PTY. LTD.
• Contact Address: 3-4 Second Avenue --; Mawson Lakes AU-SA South Australia 5095 AU
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 41316 Christy St ; Fremont, CA 94538 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3013515803
• FEI Number: 3002806902
• Name: Ellex Medical Pty Ltd
• Owner & Operator: ELLEX MEDICAL PTY. LTD.
• Contact Address: 3-4 Second Avenue --; Mawson Lakes AU-SA South Australia 5095 AU
• US Agent:
  • Bill Swaim
  • 800 8247444
  • bswaim@ellex.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3-4 Second Avenue ; Mawson Lakes South Australia, 5095 AU
• Establishment Type:
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 09342395000557 ELLEX MEDICAL PTY LTD	Ellex	2023-06-19
GUDID 09342395000540 ELLEX MEDICAL PTY LTD	Ellex	2023-06-19
GUDID 09342395000526 ELLEX MEDICAL PTY LTD	Ellex	2023-06-19
GUDID 09342395000519 ELLEX MEDICAL PTY LTD	Ellex	2023-06-19
GUDID 09342395000502 ELLEX MEDICAL PTY LTD	Ellex	2023-06-19
GUDID 09342395000373 ELLEX MEDICAL PTY LTD	Ellex	2023-06-19
GUDID 09342395000274 ELLEX MEDICAL PTY LTD	Ellex	2023-06-19
GUDID 09342395002223 ELLEX MEDICAL PTY LTD	UltraQ Reflex Neo	2023-05-09
GUDID 09342395002216 ELLEX MEDICAL PTY LTD	Tango Neo	2023-05-09
GUDID 09342395002209 ELLEX MEDICAL PTY LTD	Tango Reflex Neo	2023-05-09
PMN K222395 Ellex Medical Pty Ltd	Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo	2022-11-02
GUDID 09342395002032 ELLEX MEDICAL PTY LTD	Ellex	2022-04-08
GUDID 09342395002025 ELLEX MEDICAL PTY LTD	Ellex	2022-04-08
GUDID 09342395000892 ELLEX MEDICAL PTY LTD	Ellex	2022-04-08
PMN K212630 Ellex Medical Pty Ltd	Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo	2021-12-16
GUDID 09342395001141 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000885 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000878 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000809 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000793 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000786 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000700 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000694 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000670 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000427 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000267 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000243 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000236 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000199 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000175 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000168 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000151 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000144 ELLEX MEDICAL PTY LTD	Ellex INTEGRESCAN-RG	2021-04-21
GUDID 09342395000120 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000106 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395000090 ELLEX MEDICAL PTY LTD	Ellex	2021-04-21
GUDID 09342395001172 ELLEX MEDICAL PTY LTD	Ellex	2021-02-19
GUDID 09342395001165 ELLEX MEDICAL PTY LTD	Ellex	2021-02-19
GUDID 09342395000861 ELLEX MEDICAL PTY LTD	Ellex	2021-02-19
GUDID 09342395000687 ELLEX MEDICAL PTY LTD	Ellex	2021-02-19
GUDID 09342395000649 ELLEX MEDICAL PTY LTD	Ellex	2019-11-18
GUDID 09342395000588 ELLEX MEDICAL PTY LTD	Ellex	2019-11-18
PMN K190786 Ellex Medical Pty Ltd.	Eye Prime	2019-04-11
PMN K190786 | IYO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Prime	2019-04-11
PMN K190786 | IYO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Prime Diagnostic ophthalmic ultrasound system	2019-04-11
PMN K190786 | ITX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Prime	2019-04-11
PMN K190786 | ITX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Prime Diagnostic ophthalmic ultrasound system	2019-04-11
PMN K041108 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack	2017-12-04
PMN K041108 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Ophthalmic Microcannula	2017-12-04
PMN K050807 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Laser/Illumination Probe	2017-06-20
PMN K050807 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Laser/Aspiration probe	2017-06-20
PMN K050807 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Laser Probe	2017-06-20
PMN K103608 | IYO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	I3 System	2016-04-18
PMN K103608 | IYO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye One Diagnostic Ultrasound System	2016-04-18
PMN K103608 | IYO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Cubed-ABDU Diagnostic Ultrasound	2016-04-18
PMN K103608 | IYO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Cubed V4	2016-04-18
PMN K103608 | IYO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Cubed New Generation	2016-04-18
PMN K103608 | IYO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	EYE CUBED System -ABD Diagnostic Ultrasound	2016-04-18
PMN K103608 | ITX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	I3 System	2016-04-18
PMN K103608 | ITX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye One Diagnostic Ultrasound System	2016-04-18
PMN K103608 | ITX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Cubed-ABDU Diagnostic Ultrasound	2016-04-18
PMN K103608 | ITX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Cubed V4	2016-04-18
PMN K103608 | ITX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Eye Cubed New Generation	2016-04-18
PMN K103608 | ITX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	EYE CUBED System -ABD Diagnostic Ultrasound	2016-04-18
PMN K142398 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre Pro Scan	2015-07-30
PMN K142398 Ellex Medical Pty. Ltd.	Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow	2015-07-14
PMN K080067 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack Canaloplasty Microcatheter Kit	2014-01-08
PMN K080067 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack 250A	2014-01-08
PMN K080067 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Canaloplasty Microcatheter	2014-01-08
PMN K080067 | HMX ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack Canaloplasty Microcatheter Kit	2014-01-08
PMN K080067 | HMX ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack 250A	2014-01-08
PMN K080067 | HMX ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Canaloplasty Microcatheter	2014-01-08
PMN K062259 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iLumin	2014-01-05
PMN K062259 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Ellex iScience iLumin Fiberoptic illuminator	2014-01-05
PMN K050716 | MRH ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Opthalmic Viscoinjector	2014-01-05
PMN K122202 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	LR1532	2013-09-09
PMN K122202 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	2RT	2013-09-09
PMN K122202 Ellex Medical Pty. Ltd.	ELLEX 2RT	2013-07-01
PMN K081565 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre Yellow Pro LP561	2008-11-11
PMN K081565 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre Red/Yellow Pro L2RY	2008-11-11
PMN K081565 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre Pro family	2008-11-11
PMN K081565 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre Pro LP5532	2008-11-11
PMN K081565 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre Pro LP1RG	2008-11-11
PMN K052777 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre Pro LP1RG	2008-11-11
PMN K052777 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre LP5532	2008-11-11
PMN K052777 | GEX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre Pro LP1RG	2008-11-11
PMN K052777 | GEX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre LP5532	2008-11-11
PMN K041598 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Solitaire LP4532	2008-11-11
PMN K041598 | HQF Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Integre family	2008-11-11
PMN K021550 | GEX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Ultra Q Reflex LQP3106-U	2008-11-11
PMN K021550 | GEX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Ultra Q LQP3106-U	2008-11-11
PMN K021550 | GEX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Tango Reflex LT5106-T	2008-11-11
PMN K021550 | GEX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Tango LT5106-T	2008-11-11
PMN K021550 | GEX Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Solo LT5106-S	2008-11-11
PMN K081565 Ellex Medical Pty. Ltd.	INTEGRE PRO, MODEL L2RY	2008-07-02
PMN K080423 Ellex Medical Pty. Ltd.	INTEGRE, MODEL LP581	2008-03-11
PMN K063352 | HJO Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Ophthalmic Slit Lamp	2007-10-25
PMN K052777 Ellex Medical Pty. Ltd.	LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D	2006-03-16
PMN K041598 Ellex Medical Pty. Ltd.	LASEREX, MODEL LP4532	2004-10-06
PMN K021550 Ellex Medical Pty. Ltd.	LUMENIS SELECTA DUET	2002-08-09
HRJ Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]	Ellex Total Solution Tables	2000-05-16
PMN K992824 Ellex Medical Pty. Ltd.	LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL	1999-11-17
PMN K972514 Ellex Medical Pty. Ltd.	LASEREX LP1532 PHOTOCOAGULATOR	1997-10-03

Related Finance Registrations

NCAGE Code	ZAZ74	ELLEX MEDICAL PTY LTD
CAGE Code	ZAZ74	ELLEX MEDICAL PTY LTD