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Pegavision PEGAVISION OxyPure Silicone Hydrogel Disposable Soft Contact Lenses - HSA Registration DE0509749

Access comprehensive regulatory information for Pegavision PEGAVISION OxyPure Silicone Hydrogel Disposable 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 DE0509749 and owned by PEGAVISION CORPORATION. The device was registered on September 06, 2024.

This page provides complete registration details including product owner information, registrant details, 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
DE0509749
Pegavision PEGAVISION OxyPure Silicone Hydrogel Disposable Soft Contact Lenses
HSA Registration Number: DE0509749
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Product Description

Pegavision OxyPure Silicone Hydrogel Daily Disposable Soft Contact Lenses and Pegavision OxyPure Silicone Hydrogel Monthly Disposable Soft Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or non-aphakic persons with non-diseased eyes that are myopic and hyperopic. The lens may be worn by people who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D. Eye Care Practitioners may prescribe the lens for either single-use daily disposable wearing or frequent or planned replacement wearing.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0509749
Registration Date
September 06, 2024
Change Notification Approval Date
April 10, 2025
Retention Due Date
September 05, 2025
Product Owner
Short Name
PEGAVISION CORPORATION
Address
No.5, Shing Yeh St., Guishan Dist., Taoyuan City 333, TAIWAN
Registrant
Address
111 NORTH BRIDGE ROAD, PENINSULA PLAZA, #21-01, SINGAPORE 179098
Model Information
Model Name(s)
PEGAVISION OxyPure Silicone Hydrogel Daily Disposable Soft Contact Lenses,-12.00D to -0.25D, +0.25D to +6.00D, 1-100 pieces per pack PEGAVISION OxyPure Silicone Hydrogel Monthly Disposable Soft Contact Lenses,-12.00D to -0.25D, +0.25D to +6.00D, 1-100 pieces per pack
Model Identifier(s)
Pegavision OxyPure Silicone Hydrogel Daily Disposable Soft Contact Lenses Pegavision OxyPure Silicone Hydrogel Monthly Disposable Soft Contact Lenses