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OWNDAYS Orthokeratology Contact Lens - HSA Registration DE0510493

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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CLASS B
DE0510493
OWNDAYS Orthokeratology Contact Lens
HSA Registration Number: DE0510493
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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.

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 Owner
Short Name
OWNDAYS SINGAPORE PTE. LTD
Address
21 MERCHANT ROAD, ROYAL MERUKH S.E.A, #07-01, SINGAPORE 058267
Registrant
Address
10 KAKI BUKIT AVENUE 1, #06-08, SINGAPORE 417942
Importer
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)