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Singapore HSA registration DE0510149

CooperVision Biofinity XR Toric (comfilcon A) soft contact lenses

Singapore flagSingapore·CLASS B·CooperVision Inc.·Registered December 17, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0510149
Registration Date
December 17, 2024
Retention Due Date
December 16, 2025
Product description
BIOFINITY XR TORIC (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters.
Product Owner
Name
CooperVision Inc.
Short Name
CooperVision Inc.
Address
711 North Road, Scottsville NY 14546, UNITED STATES
Registrant
Name
COOPERVISION SINGAPORE PTE. LTD.
Address
1 TEMASEK AVENUE, MILLENIA TOWER, #39-01, SINGAPORE 039192
Importer
Name
COOPERVISION SINGAPORE PTE. LTD.Â
Address
1 TEMASEK AVENUE, MILLENIA TOWER, #39-01, SINGAPORE 039192
Model information
Model Name(s)
Biofinity XR Toric (comfilcon A) Soft Contact Lenses Sphere Power: -20.00D to +20.00D Cylinder: -0.75 to -5.75 Axis: 5° to 180°, in 5° steps Pack size: 6 pcs/pack, 1 pc trial
Model Identifier(s)
Biofinity XR Toric
About this record

Access comprehensive regulatory information for CooperVision Biofinity XR Toric (comfilcon A) soft contact lenses in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510149 and owned by CooperVision Inc.. The device was registered on December 17, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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