Singapore HSA registration DE0510423
CooperVision Biofinity XR (comfilcon A) soft contact lenses
Singapore·CLASS B·CooperVision Inc.·Registered March 05, 2025Device 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 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.
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)
About this record
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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