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Menicon Co., Ltd.

Japan · Nagoya

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 8 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

8listed device types

Class I 0Class II 6Class III 2

plus 16 registration records and 18 510(k), 23 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

11 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

30device registrations

CLASS B 24CLASS C 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IIa 4IIb 2

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

8active registrations

Class 2a 7Class 2b 1

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 States16 registration records, 18 510(k), 23 PMA, 14 excluded

Brazil3 confirmed, 1 excluded

Manufacturer names merged into this page: MENICON CO. LTD. · MENICON CO LTD. · Menicon Co., Ltd.

FDA 510(k) clearances by year

11994

11996

22000

12002

12008

12010

22011

22013

12015

12017

22018

22020

12026

FDA listed device types

Case, Contact Lens 1Products, Contact Lens Care, Rigid Gas Permeable 1Accessories, Soft Lens Products 1Lens, Contact, (Disposable) 1Lenses, Soft Contact, Daily Wear 1Lens, Contact (Other Material) - Daily 1Lens, Contact (Rigid Gas Permeable), Extended Wear 1Lens, Contact, Orthokeratology, Overnight 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253795	MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution	2026-08-13
US	K193399	Miru 1day UpSide (midafilcon A)	2020-06-17
US	K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	2020-03-02
BR	80102511721	LENTES DE CONTATO MIRU 1 MONTH MENICON	Class II
BR	80102511727	LENTES DE CONTATO MIRU 1 DAY MENICON FLAT PACK	Class II
BR	80102512378	Lentes de Contato Miru 1 Month	Class II

Menicon Co., 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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