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ALCON LABORATORIES IRELAND LTD.

Ireland · Cork Cork

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Hong Kong — 7 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

4listed device types

Class I 0Class II 0Class III 4

plus 3 registration records and 90 510(k), 1,069 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

73registered devices

Class I 8Class II 65

131 including historic records

SASaudi ArabiaSFDA

16registered imported devices

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

CACanadaMDALL

53active device licences

Class II 25Class III 27Class IV 1

204 including historic records

TWTaiwanTFDA

10valid device licences

Class III 10

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States3 registration records, 90 510(k), 1,069 PMA, 14 excluded

Brazil73 confirmed, 4 excluded

Saudi Arabia16 confirmed, 1 excluded

Canada53 confirmed, 3 excluded

Manufacturer names merged into this page: ALCON LABORATORIES IRELAND LTD. · ALCON LABORATORIES INC. · ALCON LABORATORIES, INC. · ALCON LABORATORIES, INC · ALCON. LABORATORIES, INC · ALCON LABORATORIES IRELAND LTD

FDA 510(k) clearances by year

31996

41997

101998

31999

22000

22002

22007

12012

12015

72016

42017

62018

42019

22020

32021

12022

32023

32024

32025

12026

FDA listed device types

Extended Depth Of Focus Intraocular Lens 1Lens, Multifocal Intraocular 1Intraocular Lens 1Lens, Intraocular, Toric Optics 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254052	DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal	2026-02-13
US	K252682	LenSx Laser System (8065000944)	2025-09-24
US	K243896	LenSx Laser System (8065998162)	2025-04-28
BR	81869420150	SmartCataract DX	Class I
BR	81869429012	PRECISION 7 for Astigmatism	Class II
BR	81869420005	FMS Básico US	Class II
SA	ME0000004117SFDAA00022	Monarch Loading Forceps	—
SA	ME0000004117SFDAA00024	Sutherland Handle NG	—
CA	252	SERIES 20000 LEGACY PHACOEMULSIFIER	Class III
CA	254	UNIVERSAL PHACOEMULSIFIER	Class III
CA	291	OPHTHALAS 532 LASER	Class III

ALCON LABORATORIES IRELAND LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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