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Quantel Medical EASYRET - HSA Registration DE0502261

Access comprehensive regulatory information for Quantel Medical EASYRET in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502261 and owned by Quantel Medical. The device was registered on October 11, 2018.

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
DE0502261
Quantel Medical EASYRET
HSA Registration Number: DE0502261
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Product Description

The Easyret® laser system is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including: ‐ Proliferative and nonproliferative diabetic retinopathy, ‐ Choroidal neovascularization ‐ Branch retinal vein occlusion ‐ Treatment of choroidal neovascularization associated with wet age‐related macular degeneration ‐ Retinal tears and detachments, ‐ Macular edema ‐ Retinopathy of Prematurity ‐ Iridotomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma The Indirect Ophthalmoscope or integrated Indirect Opththalsmoscope adaptor allows photocoagulation in the pigmented tissues inside the eye. This adaptor has the same clinical indications as the integrated slit lamp, but the Indirect Ophthalmoscope must only be used for posterior segment for peripheral photocoagulation.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0502261
Registration Date
October 11, 2018
Change Notification Approval Date
July 05, 2022
Retention Due Date
October 10, 2025
Product Owner
Short Name
Quantel Medical
Address
1, rue du bois joli, CS 40015, 63808 Cournon d’Auvergne Cedex, 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)
EASYRET EASYRET EASYRET EASYRET
Model Identifier(s)
H/D H/S Z/D Z/S