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ALCON SMARTCataract DX - HSA Registration DE0510520

Access comprehensive regulatory information for ALCON SMARTCataract DX in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510520 and owned by Alcon Laboratories, Inc.. The device was registered on March 30, 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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CLASS B
DE0510520
ALCON SMARTCataract DX
HSA Registration Number: DE0510520
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Product Description

The SMARTCataract DX software is indicated for use in the clinical management of ophthalmology patient data. It is used for collecting, transferring, storing, reporting, and displaying ophthalmic and demographic data, and for planning surgical lens replacement procedures and/or tracking outcomes of cataract surgery. The output from the SMARTCataract DX software is not intended to provide primary diagnosis nor to be used on a standalone basis for clinical decision-making.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510520
Registration Date
March 30, 2025
Retention Due Date
March 29, 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)
SMARTCataract DX
Model Identifier(s)
8065000877