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Long Sheng Optical Co., Ltd.

Taiwan · Tainan Chien

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 8Class II 2Class III 0

plus 18 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

2active device licences

Class II 2

12 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 States18 registration records, 12 510(k), 0 PMA, 10 excluded

Brazil0 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: YUNG SHENG OPTICAL CO., LTD. · FU SHENG OPTICAL INDUSTRY CO., LTD. · LONG SHENG PLASTICS TECH. CO., LTD

FDA 510(k) clearances by year

11994

12011

12013

22014

32015

12022

12023

12024

12025

FDA listed device types

showing 8 of 10

Lens, Contact, (Disposable) 1Lenses, Soft Contact, Daily Wear 1Spectacle, Magnifying 1Container, Specimen, Non-Sterile 1Container, Specimen Mailer And Storage, Non-Sterile 1Shield, Protective, Personnel 1Lens, Spectacle, Non-Custom (Prescription) 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K244009	Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)	2025-09-25
US	K232839	Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear	2024-12-16
US	K223585	Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear	2023-12-20
CA	107669	COFANCY COLORED SOFT CONTACT LENS	Class II
CA	111591	II99 6 MONTHS DISPOSABLE CONTACT LENSES	Class II

Long Sheng Optical 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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