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Singapore HSA registration DE0012788

AMO iDesign Refractive Studio

Singapore flagSingapore·CLASS C·AMO Manufacturing USA LLC·Registered April 22, 2013
Device classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0012788
Registration Date
April 22, 2013
Change Notification Approval Date
May 09, 2023
Retention Due Date
April 21, 2026
Product description
The iDesign Refractive Studio is indicated for the measurement of corneal topography, pupillometry, keratometry, auto‐refraction, and wavefront aberrations (including coma, spherical aberrations, trefoil, and other higher order aberrations). It is also indicated for the calculation of wavefront‐guided Laser Assisted in Situ Keratomileusis (LASIK) treatments (Advanced CustomVue treatments) for myopia, hyperopia, and mixed astigmatism.
Product Owner
Name
AMO Manufacturing USA LLC
Short Name
AMO
Address
510 Cottonwood Drive, Milpitas, CA 95035, UNITED STATES
Registrant
Name
AMO SINGAPORE PTE. LIMITED
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
AMO SINGAPORE PTE. LIMITED
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
iDesign Refractive Studio Upgrade Kit iDesign Refractive Studio iDesign Refractive Studio Table iDesign Refractive Studio Table Upgrade Kit iDesign Refractive Studio Table Accessories
Model Identifier(s)
0110-2280 0110-3442 0110-3443 0110-3520 0110-3521
About this record

Access comprehensive regulatory information for AMO iDesign Refractive Studio in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0012788 and owned by AMO Manufacturing USA LLC. The device was registered on April 22, 2013.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C