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Alcon Systane Ultra UD Lubricant Eye Drops - HSA Registration DE0507765

Access comprehensive regulatory information for Alcon Systane Ultra UD Lubricant Eye Drops in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507765 and owned by Alcon Laboratories, Inc.. The device was registered on February 09, 2023.

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
DE0507765
Alcon Systane Ultra UD Lubricant Eye Drops
HSA Registration Number: DE0507765
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Product Description

SYSTANET ULTRA UD Lubricant Eye Drops is indicated for the temporary relief of burning and irritation due to dryness of the eye. SYSTANE ULTRA UD Lubricant Eye Drops may be used to lubricate and rewet daily, extended wear and disposable silicone hydrogel and soft (hydrophilic) contact lenses. SYSTANE ULTRA UD Lubricant Eye Drops moistens your contact lenses, reduces discomfort with contact lens wear, and helps to remove particulate material that may cause irritation and/or discomfort.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0507765
Registration Date
February 09, 2023
Change Notification Approval Date
April 22, 2025
Retention Due Date
February 08, 2026
Product Owner
Short Name
Alcon
Address
6201 South Freeway, Fort Worth, Texas 76134-2099, 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 Ultra UD Lubricant Eye Drops Systane Ultra UD Lubricant Eye Drops
Model Identifier(s)
Systane Ultra UD Lubricant Eye Drops 30 x 0.7 mL Systane Ultra UD Lubricant Eye Drops 5 x 0.7 mL