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Cristalens ARTIS SYMBIOSE® - HSA Registration DE0505061

Access comprehensive regulatory information for Cristalens ARTIS SYMBIOSE® in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505061 and owned by CRISTALENS INDUSTRIE. The device was registered on October 20, 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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CLASS C
DE0505061
Cristalens ARTIS SYMBIOSE®
HSA Registration Number: DE0505061
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Product Description

This ARTIS SYMBIOSE intraocular lens is indicated for the replacement of a cataractous natural crystalline lens, for visual correction of aphakia after cataract surgery, as well as to compensate for presbyopia to allow the patient to benefit from continuous functional vision at all distances and fitted to the corneal astigmatism. It is a one-piece and posterior chamber foldable diffractive multifocal extended depth of focus intraocular lens, with binocular complementarity. It is designed for implantation in the capsular bag and to provide the function of the natural crystalline lens and appropriate optical power to achieve a sharp distance vision by its spherical equivalent power (SEQ) and its UV (UltraViolet) filter, as well as to compensate for presbyopia through its addition and, when necessary, to correct the corneal astigmatism of the patient’s eye through its cylindrical (or torical) power.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0505061
Registration Date
October 20, 2020
Change Notification Approval Date
October 04, 2022
Retention Due Date
October 19, 2025
Product Owner
Short Name
CRISTALENS INDUSTRIE
Address
4 rue Louis de Broglie, 22300 Lannion, FRANCE
Registrant
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
Address
2 KALLANG AVENUE, CT HUB, #09-19, SINGAPORE 339407 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid) ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid) ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid) ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid) ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid) ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid) ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid) ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid) ARTIS SYMBIOSE® (SEQ: +9.0D to +36.0D by 0.5D increments with Addition Profile: Mid)
Model Identifier(s)
ARTIS SYMBIOSE® MID +10.0D ARTIS SYMBIOSE® MID +10.5D ARTIS SYMBIOSE® MID +11.0D ARTIS SYMBIOSE® MID +11.5D ARTIS SYMBIOSE® MID +12.0D ARTIS SYMBIOSE® MID +12.5D ARTIS SYMBIOSE® MID +13.0D ARTIS SYMBIOSE® MID +13.5D ARTIS SYMBIOSE® MID +14.0D