Singapore HSA registration DE0510520
ALCON SMARTCataract DX
Singapore·CLASS B·Alcon Laboratories, Inc.·Registered March 30, 2025Device 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 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.
Product Owner
- Short Name
- Alcon
- Address
- 6201 South Freeway, Fort Worth, Texas 76134-2099, UNITED STATES
Registrant
- Name
- ALCON PTE LTD
- Address
- 1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628
Importer
- Name
- ALCON PTE LTD
- Address
- 1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628
Model information
- Model Name(s)
- SMARTCataract DX
- Model Identifier(s)
- 8065000877
About this record
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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