HomeMalaysiaSUPERVISION OPTIMAX SDN BHD

SUPERVISION OPTIMAX SDN BHD

Malaysia · Sungai Buloh
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea — 5 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
2listed device types
Class I 0Class II 2Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class II 6
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
0active device licences
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
7device registrations
CLASS B 7
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States2 registration records, 2 510(k), 0 PMA, 1 excluded
Brazil6 confirmed, 0 excluded
Manufacturer names merged into this page: SUPERVISION OPTIMAX SDN BHD

Company information

Country
Malaysia
City
Sungai Buloh

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

12017 · K162223
12018 · K180985

FDA listed device types

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

Registration details (sample)

MarketIdentifierNameClass / date
USK180985Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses2018-06-08
USK162223Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)2017-01-04
BR80105840007LENTE DE CONTATO GELATINOSA ASPHERIC AVEOClass II
BR80105840008LENTE DE CONTATO GELATINOSA ASPHERIC AVEO 1-DAYClass II
BR80105840011Lente de Contato Gelatinosa Tórica AVEO 1-MONTHClass II

Similar companies

AAMEDIX GLOVE SDN BHD
Malaysia · markets 3
Advanced Safety Lifecare Sdn. Bhd.
Malaysia · markets 0
Angel sports sdn.bhd
Malaysia · markets 1
ATL Products Tech Sdn Bhd
Malaysia · markets 0
CCB Medical Devices Sdn Bhd
Malaysia · markets 2
CONCH HYGIENE PRODUCTS SDN BHD
Malaysia · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →