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CooperVision Aqualens 24H NXT Toric (fanfilcon A) soft contact lenses - HSA Registration DE0505793

Access comprehensive regulatory information for CooperVision Aqualens 24H NXT Toric (fanfilcon 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 DE0505793 and owned by CooperVision Inc.. The device was registered on May 18, 2021.

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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CLASS B
DE0505793
CooperVision Aqualens 24H NXT Toric (fanfilcon A) soft contact lenses
HSA Registration Number: DE0505793
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Product Description

AQUALENS 24H NXT TORIC (fanfilcon A) TORIC Soft 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 -10.00 diopters.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0505793
Registration Date
May 18, 2021
Change Notification Approval Date
October 08, 2021
Retention Due Date
May 17, 2025
Product Owner
Short Name
CooperVision Inc.
Address
711 North Road, Scottsville, New York 14546, UNITED STATES
Registrant
Address
1 TEMASEK AVENUE, MILLENIA TOWER, #39-01, SINGAPORE 039192
Importer
Address
1 TEMASEK AVENUE, MILLENIA TOWER, #39-01, SINGAPORE 039192
Model Information
Model Name(s)
Aqualens 24H NXT Toric (fanfilcon A) Soft Contact Lenses [Diopter range: -20.00D to -0.25D, +0.25D to +20.00D][Cylinder: -0.75D, -1.25D, -1.75D, -2.25D][Axis: 10° to 180° (10° steps)][Pack size: 3pc]
Model Identifier(s)
Aqualens 24H NXT Toric (fanfilcon A) Soft Contact Lenses