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Quantel Medical Vitra 810 - HSA Registration DE0506627

Access comprehensive regulatory information for Quantel Medical Vitra 810 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506627 and owned by Quantel Medical. The device was registered on February 07, 2022.

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
DE0506627
Quantel Medical Vitra 810
HSA Registration Number: DE0506627
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Product Description

The VITRA 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following: - Retinal photocoagulation for the treatment of: o Diabetic retinopathy including: Nonproliferative retinopathy Macular edema Proliferative retinopathy o Retinal Tears, Detachments and Holes o Lattice degeneration o Age-related macular degeneration (AMD) with choroidal neovascularizations (CNV) o Retinopathy of prematurity o Sub-retinal (choroidal) neovascularization o Central and Branch Retinal Vein Occlusion - Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the treatment of glaucoma, including: o Primary open angle o Closed angle o Refractory Glaucoma (recalcitrant/uncontrolled)

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0506627
Registration Date
February 07, 2022
Change Notification Approval Date
July 05, 2022
Retention Due Date
February 06, 2026
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)
Vitra 810 SubCyclo Probe Endo-Ocular Probes- Curved, 20 Gauges Endo-Ocular Probes- Straight, 20 Gauges Endo-Ocular Probes- Flexible Curved, 23 Gauges Endo-Ocular Probes- Straight, 23 Gauges Endo-Ocular Probes- Steerable, 23 Gauges Endo-Ocular Probes- Flexible Curved, 25 Gauges Endo-Ocular Probes- Straight, 25 Gauges Endo-Ocular Probes- Steerable, 25 Gauges
Model Identifier(s)
PABX0027C XLCYCLO XLEND20C XLEND20D XLEND23C XLEND23D XLEND23DIR XLEND25C XLEND25D XLEND25DIR