Singapore HSA registration DE0500535
Euclid Vision Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
Singapore·CLASS B·Euclid Vision Corporation·Registered May 12, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0500535
- Registration Date
- May 12, 2017
- Change Notification Approval Date
- November 06, 2023
- Retention Due Date
- May 11, 2026
Product description
Euclid Contact Lenses for Orthokeratology are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear for the temporary reduction of myopia up to 5.00 diopters in eyes with astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system. Note: To maintain the Orthokeratology effect of myopia reduction, overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e.g., night driving), visual fluctuations and changes in intended correction.
Product Owner
- Short Name
- Euclid Vision Corporation
- Address
- 45472 Holiday Drive, Suite 7, Sterling, VA 20166, UNITED STATES
Registrant
- Address
- 116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
- Address
- 215 KALLANG BAHRU, HILITE INDUSTRIAL BUILDING, #04-00, SINGAPORE 339346 15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Model information
- Model Name(s)
- Euclid Vision Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear [Power: +1.50 to -5.00 Diopters, Base Curve: 7.30mm to 10.15mm, Diameter: 9.6mm to 11.6mm, Center Thickness: 0.20mm to 0.32mm][Pack of 1] Euclid Vision Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear [Power: +1.50 to -5.00 Diopters, Base Curve: 7.30mm to 10.15mm, Diameter: 9.6mm to 11.6mm, Center Thickness: 0.20mm to 0.32mm][Pack of 1]
- Model Identifier(s)
- Emerald � Blue Tint Emerald � Green Tint
About this record
Access comprehensive regulatory information for Euclid Vision Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500535 and owned by Euclid Vision Corporation. The device was registered on May 12, 2017.
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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