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Alcon SYSTANE™ HYDRATION UD Lubricant Eye Drops - HSA Registration DE0019212

Access comprehensive regulatory information for Alcon SYSTANE™ HYDRATION UD Lubricant Eye Drops in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019212 and owned by Alcon Laboratories, Incorporated. The device was registered on April 28, 2017.

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 C
DE0019212
Alcon SYSTANE™ HYDRATION UD Lubricant Eye Drops
HSA Registration Number: DE0019212
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Product Description

SYSTANE™ HYDRATION UD Lubricant Eye Drops is indicated for the temporary relief of burning and irritation due to dryness of the eye. SYSTANE™ HYDRATION UD Lubricant Eye Drops may be used to lubricate and rewet daily, extended wear and disposable silicone hydrogel and soft (hydrophilic) contact lenses.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0019212
Registration Date
April 28, 2017
Change Notification Approval Date
November 20, 2024
Retention Due Date
April 27, 2026
Product Owner
Short Name
Alcon Laboratories, Incorporated
Address
6201 South Freeway, Fort Worth, Texas 76134-2099, USA, UNITED STATES
Registrant
Address
1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628
Importer
Address
1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628
Model Information
Model Name(s)
SYSTANE™ HYDRATION UD Lubricant Eye Drops SYSTANE™ HYDRATION UD Lubricant Eye Drops
Model Identifier(s)
30 vials 5 Vials