Singapore HSA registration DE0504004
Seinoh Optical BioThin Daily Disposable Soft Contact Lens
Singapore·CLASS B·Seinoh Optical Co., Ltd.·Registered January 08, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0504004
- Registration Date
- January 08, 2020
- Retention Due Date
- January 07, 2026
Product description
The Biothin Daily Disposable Soft Contact Lens is indicated for single-use disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.000 to +20.00D. The lens may be worn by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens for single use and patients are instructed to dispose of the lens at each removal. The Biothin Daily Disposable Soft Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Product Owner
- Short Name
- Seinoh Optical Co., Ltd.
- Address
- 3F, No.14, Wucyuan 3rd Rd.,, Sinjhuang Dist.,, New Taipei City, 242,, TAIWAN
Registrant
- Name
- AOS PTE. LTD.
- Address
- 46 LORONG 17 GEYLANG, ENTERPRISE INDUSTRIAL BUILDING, #06-02, SINGAPORE 388568
Importer
- Name
- AOS PTE. LTD.
- Address
- 46 LORONG 17 GEYLANG, ENTERPRISE INDUSTRIAL BUILDING, #06-02, SINGAPORE 388568
Model information
- Model Name(s)
- BioThin Daily Disposable Soft Contact Lens [Diopter range: -6.00D to +6.00D (0.25D steps), +20.00D to +6.50D, -6.50D to -20.00D (0.50D steps)], (Pack of 5, 10, 30, 90)
- Model Identifier(s)
- BioThin Daily - Tint 55
About this record
Access comprehensive regulatory information for Seinoh Optical BioThin Daily Disposable Soft 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 DE0504004 and owned by Seinoh Optical Co., Ltd.. The device was registered on January 08, 2020.
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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