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Home›Japan›ASAHI LITE OPTICAL CO., LTD.

ASAHI LITE OPTICAL CO., LTD.

Japan · Sabae City Fukui Pref
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
7valid device licences
Class I 7
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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 States1 registration records, 6 510(k), 0 PMA, 16 excluded
Brazil0 confirmed, 6 excluded
Saudi Arabia3 confirmed, 0 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: ASAHI LITE OPTICAL CO., LTD. · Asahi Lite Optical Co., Ltd · Asahi Lite Optical · Asahi Lite Optical Co. LTD
Same-named companies — This database also contains companies with near-identical names: Korea Asahi Optical Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Sabae City Fukui Pref

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

11986 · K861960
31987 · K872089
21989 · K885133

FDA listed device types

Lens, Spectacle, Non-Custom (Prescription) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK885133APACERAM ARTIFICIAL DENTAL IMPLANT1989-09-05
USK893134APACERAM OSSICULAR PROSTHESIS1989-08-03
USK872089APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)1987-08-14
SAME0000009571SFDAA00001TRIANO—
SAME0000003615SFDAA00143CLEAR, Trivex BluLoc—

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