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Singapore HSA registration DE0505951

HumanOptics Artificial Iris FiberFree Intraocular Implant

Singapore flagSingapore·CLASS C·HumanOptics Holding AG·Registered July 01, 2021
Device classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0505951
Registration Date
July 01, 2021
Change Notification Approval Date
May 07, 2024
Retention Due Date
June 30, 2025
Product description
The ARTIFICIALIRIS is intended for use as an iris prosthesis for the treatment of iris defects in eyes which are pseudophakic, aphakic or require cataract extraction. The ARTIFICIALIRIS is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia.
Product Owner
Name
HumanOptics Holding AG
Short Name
HumanOptics Holding AG
Address
Spardorfer Str. 150, 91054 Erlangen, GERMANY
Registrant
Name
Transmedic Pte Ltd
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
Name
SWISSMED PTE LTD TRANSMEDIC PTE LTD
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)
Artificial Iris FiberFree
Model Identifier(s)
95242
About this record

Access comprehensive regulatory information for HumanOptics Artificial Iris FiberFree Intraocular Implant in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505951 and owned by HumanOptics Holding AG. The device was registered on July 01, 2021.

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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