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Ellex Medical Pty, Ltd.

Australia · Mawson Lakes

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 11 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

6active device licences

Class II 1Class III 5

18 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

10device registrations

CLASS B 2CLASS C 8

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

9active ARTG entries

Class I 4IIa 1IIb 4

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 13 510(k), 0 PMA, 1 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Ellex Medical Pty Ltd · ELLEX MEDICAL PTY LTD

Business registration

Legal name: ELLEX MEDICAL PTY LTD
ABN: 35008276060
Registration status: Active
Legal form: Australian Private Company
Registered address: SA, 5095

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11997

11999

12001

12002

12004

12006

22008

12013

12015

12019

12021

12022

FDA listed device types

Powered Laser Surgical Instrument 1Laser, Ophthalmic 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Table, Instrument, Powered, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222395	Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo	2022-11-02
US	K212630	Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo	2021-12-16
US	K190786	Eye Prime	2019-04-11
CA	312	OPHTHALMIC YAG LASER	Class III
CA	65467	ELLEX SUPER Q	Class III
CA	67860	ELLEX SOLITAIRE	Class III