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Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear - HSA Registration DE0510644

Access comprehensive regulatory information for Euclid Orthokeratology (tisilfocon 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 DE0510644 and owned by Euclid Vision Corporation. The device was registered on April 29, 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
DE0510644
Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
HSA Registration Number: DE0510644
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Product Description

Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear 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 with eyes having astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510644
Registration Date
April 29, 2025
Retention Due Date
April 28, 2026
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
15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Model Information
Model Name(s)
Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear (1.50 D to 5.00 D) (Pack 1 or 2) Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear (1.50 D to 5.00 D) (Pack 1 or 2)
Model Identifier(s)
Tisilfocon A, Toric Green Tisilfocon A, Toric blue