Singapore HSA registration DE0506627
Quantel Medical Vitra 810
Singapore·CLASS C·Quantel Medical·Registered February 07, 2022Device 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 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)
Product Owner
- Name
- Quantel Medical
- 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
About this record
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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