HomeTaiwanYUNG SHENG OPTICAL CO., LTD.

YUNG SHENG OPTICAL CO., LTD.

Taiwan · Taichung City
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia, Russia — 6 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
4listed device types
Class I 2Class II 2Class III 0
plus 12 registration records and 11 510(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
10device registrations
CLASS B 10
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
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 States12 registration records, 11 510(k), 0 PMA, 1 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: YUNG SHENG OPTICAL CO., LTD. · BIA YUNG OPTICAL (BOLUO) COMPANY LIMITED

Company information

Country
Taiwan
City
Taichung City

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11994
12013
22014
32015
12022
12023
12024
12025

FDA listed device types

Lens, Contact, (Disposable) 1Lenses, Soft Contact, Daily Wear 1Sunglasses (Non-Prescription Including Photosensitive) 1Frame, Spectacle 1

Registration details (sample)

MarketIdentifierNameClass / date
USK244009Pure 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
USK232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear2024-12-16
USK223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear2023-12-20
CA107669COFANCY COLORED SOFT CONTACT LENSClass II
CA111591II99 6 MONTHS DISPOSABLE CONTACT LENSESClass II

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