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NIDEK OPHTHALMIC YAG LASER SYSTEM YC-200 - HSA Registration DE0503459

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.

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CLASS C
DE0503459
NIDEK OPHTHALMIC YAG LASER SYSTEM YC-200
HSA Registration Number: DE0503459
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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.

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 Owner
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