Singapore HSA registration DE0510493

OWNDAYS Orthokeratology Contact Lens

Singapore·CLASS B·OWNDAYS SINGAPORE PTE. LTD·Registered March 24, 2025

Device classification

Device Class: CLASS B
Medical Speciality Area: Ophthalmology

Registration information

Registration Number: DE0510493
Registration Date: March 24, 2025
Retention Due Date: March 23, 2026

Product description

OWNDAYS Ortho-K (Hexafocon A) Contact Lenses 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 7.00 diopters.

Product Owner

Name: OWNDAYS SINGAPORE PTE. LTD
Short Name: OWNDAYS SINGAPORE PTE. LTD
Address: 21 MERCHANT ROAD, ROYAL MERUKH S.E.A, #07-01, SINGAPORE 058267

Registrant

Name: OCULUS PRIVATE LIMITED
Address: 10 KAKI BUKIT AVENUE 1, #06-08, SINGAPORE 417942

Importer

Name: OCULUS VISIONCARE (S) PTE LTD
Address: 10 KAKI BUKIT AVENUE 1, #06-08, SINGAPORE 417942

Model information

Model Name(s): Ortho-K Contact Lens [Target Power (-7.00D to +7.00D)] [Base curve: 7.00mm to 10.30mm, Diameter: 9.80mm to 11.60mm] [pack of 1-100] Ortho-K Contact Lens [Target Power (-7.00D to +7.00D)] [Base curve: 7.00mm to 10.30mm, Diameter: 9.80mm to 11.60mm] [pack of 1-100] Ortho-K Contact Lens [Target Power (-7.00D to +7.00D)] [Base curve: 7.00mm to 10.30mm, Diameter: 9.80mm to 11.60mm] [pack of 1-100] Ortho-K Contact Lens [Target Power (-7.00D to +7.00D)] [Base curve: 7.00mm to 10.30mm, Diameter: 9.80mm to 11.60mm] [pack of 1-100] Ortho-K Contact Lens [Target Power (-7.00D to +7.00D)] [Base curve: 7.00mm to 10.30mm, Diameter: 9.80mm to 11.60mm] [pack of 1-100] Ortho-K Contact Lens [Target Power (-7.00D to +7.00D)] [Base curve: 7.00mm to 10.30mm, Diameter: 9.80mm to 11.60mm] [pack of 1-100]
Model Identifier(s): Ortho-K Contact Lens (Blue) Ortho-K Contact Lens (Clear) Ortho-K Contact Lens (Green) Ortho-K Contact Lens (Ice Blue) Ortho-K Contact Lens (Red) Ortho-K Contact Lens (Yellow)

About this record

Access comprehensive regulatory information for OWNDAYS Orthokeratology Contact Lens in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510493 and owned by OWNDAYS SINGAPORE PTE. LTD. The device was registered on March 24, 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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