Establishment Registration & Device Listing

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Product Code : LPM

Establishment
Name

Registration Number

Current
Registration Yr

CIBA VISION CORPORATION

GA/USA

1053053

2013

lenses, soft contact, extended wear - Precision UV®

Specification Developer; Complaint File Establishment

lenses, soft contact, extended wear - DuraSoft® 3; DuraSoft® 3 ColorBlends®; DuraSoft® 3 Colors; DuraSoft® 3 Complements®; DuraSoft® 3 LiteTint®; DuraSoft® 3 OptiFit® Toric; DuraSoft® 3 OptiFit® Toric ColorBlends®; DuraSoft® 3 OptiFit® Toric Colors; DuraSoft® 3 OptiFit® Toric Complements®; DuraSoft® 3 OptiFit® Toric LiteTint®; DuraSoft® 3 UV; DuraSoft® 3 UV Colors; DuraSoft® 3 UV Complements®; DuraSoft® 3 UV Handling Tint; DuraSoft® 3 UV OptiFit® Toric; DuraSoft® 3 UV OptiFit® Toric Colors; DuraSoft® 3 UV OptiFit® Toric Complements®; DuraSoft® 3 UV OptiFit® Toric Handling Tint; FreshLook ColorBlends®; FreshLook Dimensions®; FreshLook Radiance?; FreshLook Toric ColorBlends®; FreshLook®; FreshLook® Color Enhancers; FreshLook® Colors; FreshLook® Handling Tint; FreshLook® Progressive Bifocal Handling Tint; FreshLook® Toric; FreshLook® Toric Colors; FreshLook® Toric Colors Enhancers; FreshLook® Toric Handling Tint; Wild Eyes®; WildEyes® 2 Go

Repackager/Relabeler; Specification Developer; Complaint File Establishment

lenses, soft contact, extended wear - Focus® 1-2 Week Softcolors®; Focus® 1-2 Week Visitint®; Focus® Monthly Softcolors®; Focus® Monthly Toric Visitint®; Focus® Monthly Visitint®; Focus® Progressives Visitint®; Softcon® EW

Specification Developer; Complaint File Establishment

lenses, soft contact, extended wear - AIR OPTIX® AQUA; AIR OPTIX® AQUA MULTIFOCAL; AIR OPTIX® for ASTIGMATISM (previously O2OPTIX? Toric; O2OPTIX? Toric for Astigmatism; O2OPTIX? for Astigmatism); AIR OPTIX® NIGHT & DAY® AQUA; NIGHT & DAY® (formerly, Focus NIGHT & DAY® and commercialized in some markets as AIR OPTIX® NIGHT & DAY®); O2OPTIX? (Commercialized in some markets as AIR OPTIX®)

Repackager/Relabeler; Specification Developer; Complaint File Establishment

CIBA VISION JOHOR SDN.BHD.,

MALAYSIA

3006186389

2013

lenses, soft contact, extended wear - AIR OPTIX® AQUA; AIR OPTIX® AQUA MULTIFOCAL; AIR OPTIX® for ASTIGMATISM (previously O2OPTIX? Toric; O2OPTIX? Toric for Astigmatism; O2OPTIX? for Astigmatism); AIR OPTIX® NIGHT & DAY® AQUA; NIGHT & DAY® (formerly, Focus NIGHT & DAY® and commercialized in some markets as AIR OPTIX® NIGHT & DAY®); O2OPTIX? (Commercialized in some markets as AIR OPTIX®)

Manufacturer

COASTAL CONTACTS INC.

CANADA

3006066935

2013

lenses, soft contact, extended wear - Lenses, Soft Contact, Daily Wear

Foreign Exporter

COOPERVISION CARIBBEAN CORPORATION

PR/USA

2640128

2013

lenses, soft contact, extended wear - Biomedics 38; Biomedics 38 UV; Edge III Biomedics 38 (For Export Only); Edge III Versa-Scribe DW/FW (For Export Only); Edge III Versa-Scribe FW/DW (For Export Only); Edge III XT (For Export Only); Extended Wear; Frequency 38 IFor Export Only); Mediflex 38 (For Export Only); polymacon; Pro-fit (For Export Only); Silver 07 (For Export Only)

Contract Manufacturer; Manufacturer

lenses, soft contact, extended wear - Biomedics 1 day Extra (For Export Only); Biomedics 55; Biomedics 55 (For Export Only); Biomedics 55 Aspheric; Biomedics 55 UV; Biomedics Toric; Biomedics toric (For Export Only); Edge III 55; Edge III 55 FW (For Export Only); For Daily Wear or Extended Wear; Mediflex 55 (For Export Only); Mediflex toric (For Export Only); ocufilcon D Soft Contact Lens

Contract Manufacturer; Manufacturer; Repackager/Relabeler

lenses, soft contact, extended wear - Biofinity; Biofinity Toric; Biofinity toric (For Export Only); comfilcon A; DK128; DK128 Toric; SiH 48; SiH 48 Toric; silicon hydrogel soft contact lens

Manufacturer

COOPERVISION INC.

NY/USA

3005724763

2013

lenses, soft contact, extended wear - Biomedics 1 day Extra (For Export Only); Biomedics 55; Biomedics 55 (For Export Only); Biomedics 55 Aspheric; Biomedics 55 UV; Biomedics Toric; Biomedics toric (For Export Only); Edge III 55; Edge III 55 FW (For Export Only); For Daily Wear or Extended Wear; Mediflex 55 (For Export Only); Mediflex toric (For Export Only); ocufilcon D Soft Contact Lens

Repackager/Relabeler

lenses, soft contact, extended wear - CooperFlex Premium (For Export Only); Expressions Colors (For Export Only); Extended Wear; Frequency 55 apsheric (For Export Only); methafilcon A; methafilcon B

Repackager/Relabeler

lenses, soft contact, extended wear - Biomedics 38; Biomedics 38 UV; Edge III Biomedics 38 (For Export Only); Edge III Versa-Scribe DW/FW (For Export Only); Edge III Versa-Scribe FW/DW (For Export Only); Edge III XT (For Export Only); Extended Wear; Frequency 38 IFor Export Only); Mediflex 38 (For Export Only); polymacon; Pro-fit (For Export Only); Silver 07 (For Export Only)

Repackager/Relabeler

lenses, soft contact, extended wear - Biofinity; Biofinity Toric; Biofinity toric (For Export Only); comfilcon A; DK128; DK128 Toric; SiH 48; SiH 48 Toric; silicon hydrogel soft contact lens

Repackager/Relabeler

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Establishment Registration & Device Listing

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