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ALCON NGENUITY™ 3D VISUALIZATION SYSTEM - HSA Registration DE0510716

Access comprehensive regulatory information for ALCON NGENUITY™ 3D VISUALIZATION SYSTEM in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510716 and owned by Alcon Laboratories, Inc.. The device was registered on May 13, 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
DE0510716
ALCON NGENUITY™ 3D VISUALIZATION SYSTEM
HSA Registration Number: DE0510716
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Product Description

The NGenuity™ 3D Visualization System is intended to aid in visualization during ophthalmic surgery. It is used for providing magnified stereoscopic images of ocular tissue in real-time or from recordings during ophthalmic surgery.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510716
Registration Date
May 13, 2025
Retention Due Date
May 12, 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)
NGENUITY™ 3D VISUALIZATION SYSTEM NGENUITY™ 3D VISUALIZATION SYSTEM + K400 Plus Keyboard
Model Identifier(s)
8065000399 8065000588