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CooperVision Limited

USA · San Ramon

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Hong Kong, Russia — 5 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 0Class II 3Class III 2

plus 60 registration records and 97 510(k), 573 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class II 15

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 9

17 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

30valid listings

Class II 30

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States60 registration records, 97 510(k), 573 PMA, 8 excluded

Brazil15 confirmed, 3 excluded

Canada9 confirmed, 3 excluded

Manufacturer names merged into this page: CooperVision, Inc. · COOPERVISION INC. · COOPERVISION, INC. · CooperVision Limited · COOPERVISION LTD. · COOPERVISION, INC

FDA 510(k) clearances by year

11998

21999

42000

12002

12003

32004

22005

12006

22008

12010

52011

12012

32013

12016

12018

12019

22020

12021

12022

12024

FDA listed device types

Accessories, Soft Lens Products 1Lens, Contact, (Disposable) 1Lenses, Soft Contact, Daily Wear 1Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia 1Lenses, Soft Contact, Extended Wear 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K234127	Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker	2024-01-25
US	K220070	MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens	2022-02-04
US	K213164	Avaira Vitality	2021-10-26
BR	80130430055	LENTES DE CONTATO FAMÍLIA IWEAR OXYGEN	Class II
BR	80130430048	LENTES DE CONTATO FAMÍLIA STENFILCON A	Class II
BR	80130430053	LENTES DE CONTATO SOMOFILCON A MENSAL	Class II
CA	7713	LL-38 (POLYMACON) SOFT CONTACT LENS	Class II
CA	7729	LL-55 (METAFILCON A) SOFT CONTACT LENS	Class II
CA	3274	(OMAFILCON A) SOFT CONTACT LENSES	Class II

CooperVision Limited

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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