HomeTaiwanUNICON OPTICAL CO., LTD.

UNICON OPTICAL CO., LTD.

Taiwan · Hsinchu County
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Israel, Russia — 4 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
2listed device types
Class I 0Class II 2Class III 0
plus 5 registration records and 5 510(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
4active device licences
Class II 4
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States5 registration records, 5 510(k), 0 PMA
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: UNICON OPTICAL CO., LTD.

Company information

Country
Taiwan
City
Hsinchu County

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

12014 · K141917
22019 · K191929
12022 · K213216
12024 · K241707

FDA listed device types

Lens, Contact, (Disposable) 1Lenses, Soft Contact, Daily Wear 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™2024-07-12
USK213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens2022-01-18
USK191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens2019-09-17
CA88405LOGIC COLORVIEW DISPOSABLE SOFT CONTACT LENSESClass II
CA100112CONTACT LENSES (POLOXIFILCON)Class II
CA100491DISPOSABLE SOFT CONTACT LENSES (HEMA+MAA)Class II

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