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CooperVision Biofinity XR (comfilcon A) soft contact lenses - HSA Registration DE0510423

Access comprehensive regulatory information for CooperVision Biofinity XR (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 DE0510423 and owned by CooperVision Inc.. The device was registered on March 05, 2025.

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
DE0510423
CooperVision Biofinity XR (comfilcon A) soft contact lenses
HSA Registration Number: DE0510423
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Product Description

Biofinity XR (comfilcon A) Soft Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510423
Registration Date
March 05, 2025
Retention Due Date
March 04, 2026
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)
Biofinity XR (comfilcon A) [Pack size: 6pk, 1pc] [Sphere Power: -12.50 D to -20.00 D in 0.50D steps; +8.50 D to +15.00 D in 0.50D steps]
Model Identifier(s)
Biofinity XR (comfilcon A)