FDA.reportPublic FDA data

Harleco

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30154308603015430860HARLEIGH (MALAYSIA) SDN. BHD.1N2026-01-01No 4, Jalan Tahana,Tampoi Industrial Estate Johor Bahru MY 80350

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2318341999450654P010019FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSESLPM2001-10-11
2318341808253216K210436Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 AsphereLPL2021-04-12
2318341681873103K182902Precision1LPL2018-12-11
2318341357291616K172600AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS MultifocalLPL2017-10-25
2318341001997692K133176AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCALLPL2014-01-29
2318341464246779K123994DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCALLPL2013-02-21
2318341321864077K072777CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSESLPL2008-01-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPL62021-04-12
LPM12001-10-11

PMN#

MERCATOR

1999-01-27

HARLEY STREET SOFTWARE LTD.

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