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Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland

Ireland · Waterford Munster

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

210listed device types

Class I 155Class II 40Class III 12unclassified 3

plus 684 registration records and 144 510(k), 925 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

163registered devices

Class I 76Class II 87

184 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

26active device licences

Class II 18Class III 8

178 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States684 registration records, 144 510(k), 925 PMA

Brazil163 confirmed, 0 excluded

Canada26 confirmed, 0 excluded

Manufacturer names merged into this page: Bausch & Lomb Incorporated · Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre · Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland · BAUSCH & LOMB CORPORATION · BAUSCH & LOMB INC. · BAUSCH & LOMB, INC.

Same-named companies — This database also contains companies with near-identical names: Bausch and Lomb, Incorporated, Bausch & Lomb Healthcare and Optics Worldwide, Bausch + Lomb Ireland Limited, Bausch & Lomb Pharmaceutical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

42006

32007

52008

22009

12010

12011

52012

62013

42014

22015

32016

72017

32018

22019

22020

32021

12022

22023

32024

22026

FDA listed device types

showing 8 of 210

Cannula, Trocar, Ophthalmic 1Spectacle, Magnifying 1Chisel, Surgical, Manual 1Perforator, Ear-Lobe 1Syringe, Restorative And Impression Material 1Knife, Nasal 1Stripper, Surgical 1Gag, Mouth 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261264	Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+	2026-05-15
US	K252052	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)	2026-03-25
US	K242389	EyeGility Inserter for Preloaded enVista IOLs	2024-10-10
BR	80136060091	Instrumentos para microcirurgias oftalmológicas - Pinças em aço inoxid	Class I
BR	10196150012	LENTES DE CONTATO OPTIMA 38 BAUSCH & LOMB	Class II
BR	80136060263	Instrumentais para microcirurgia oftalmológica - Dilatador lacrimal #2	Class I
CA	5136	STARTER KIT	Class II
CA	5962	PHACOTRON GOLD MICROSURGICAL SYSTEM ACCESSORIES	Class II
CA	6393	BOSTON SIMPLICITY STARTER KIT	Class II

Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland

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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