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United Contact Lens, Inc.

USA · Arlington

✓ 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

7listed device types

Class I 0Class II 4Class III 2unclassified 1

plus 43 registration records and 41 510(k), 25 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class II 16

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

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

0valid device licences

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 States43 registration records, 41 510(k), 25 PMA, 4 excluded

Brazil16 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ART OPTICAL CONTACT LENS, INC. · UNITED CONTACT LENS INC · VISIONARY CONTACT LENS, INC. · MI GWANG CONTACT LENS CO., LTD. · CARDINAL CONTACT LENS INC. · G&G CONTACT LENS

Same-named companies — This database also contains companies with near-identical names: American Contact Lens, Inc., G&G CONTACT LENS, N & N Contact Lens Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11986

11989

21994

11995

41996

21999

12000

52001

32002

22003

22004

22005

12006

22008

12010

12012

12013

22015

12017

12023

FDA listed device types

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230824	IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)	2023-09-06
US	K172314	Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)	2017-09-20
US	K152046	Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)	2015-11-24
BR	82170409003	LENTES SOFT UNIVERSE CLEAR	Class II
BR	81325999064	Lentes de Contato Gelatinosas	Class II
BR	81325999056	Lentes de Contato Gelatinosas	Class II
CA	80673	CARDINALSOFT	Class II

United Contact Lens, Inc.

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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