Singapore HSA registration DE0510716
ALCON NGENUITY™ 3D VISUALIZATION SYSTEM
Singapore·CLASS B·Alcon Laboratories, Inc.·Registered May 13, 2025Device 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 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.
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)
- NGENUITY™ 3D VISUALIZATION SYSTEM NGENUITY™ 3D VISUALIZATION SYSTEM + K400 Plus Keyboard
- Model Identifier(s)
- 8065000399 8065000588
About this record
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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