Singapore HSA registration DE0503459
NIDEK OPHTHALMIC YAG LASER SYSTEM YC-200
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0503459
- Registration Date
- August 09, 2019
- Change Notification Approval Date
- February 26, 2025
- Retention Due Date
- August 08, 2025
Product description
The Ophthalmic YAG LASER SYSTEM YC-200 is indicated for the performance of posterior capsulotomy, posterior membranectomy, pupillay membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.
Product Owner
- Name
- NIDEK CO., LTD
- Short Name
- NIDEK CO., LTD
- Address
- 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, JAPAN
Registrant
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, SIGNATURE, THE, #06-14, SINGAPORE 486066
Importer
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, SIGNATURE, THE, #06-14, SINGAPORE 486066 6 UBI ROAD 1, WINTECH CENTRE, #03-12, SINGAPORE 408726
Model information
- Model Name(s)
- OPHTHALMIC YAG LASER SYSTEM OPHTHALMIC YAG LASER SYSTEM Illumination tower (Split mirror illumination)
- Model Identifier(s)
- YC-200 YC-200 S Plus YC020-4501
About this record
Access comprehensive regulatory information for NIDEK OPHTHALMIC YAG LASER SYSTEM YC-200 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503459 and owned by NIDEK CO., LTD. The device was registered on August 09, 2019.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C