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Singapore HSA registration DE0505875

CooperVision 56% (somofilcon A) 1-day silicone hydrogel soft contact lenses

Singapore flagSingapore·CLASS B·CooperVision Inc.·Registered June 11, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0505875
Registration Date
June 11, 2021
Change Notification Approval Date
March 22, 2023
Retention Due Date
June 10, 2025
Product description
The 56% 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity
Product Owner
Name
CooperVision Inc.
Short Name
CooperVision Inc.
Address
711 North Road, Scottsville, New York 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)
CooperVision 56% (somofilcon A) 1-day silicone hydrogel soft contact lenses [Diopter range:-10.00D to -0.25D, +0.25D to +8.00D][Pack size: 5pcs, 30pcs]
Model Identifier(s)
CooperVision 56% (somofilcon A) 1-day silicone hydrogel
About this record

Access comprehensive regulatory information for CooperVision 56% (somofilcon A) 1-day silicone hydrogel 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 DE0505875 and owned by CooperVision Inc.. The device was registered on June 11, 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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