Pure Global

Quantel Medical Vitra 689 - HSA Registration DE0506177

Access comprehensive regulatory information for Quantel Medical Vitra 689 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506177 and owned by Quantel Medical. The device was registered on September 14, 2021.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0506177
Quantel Medical Vitra 689
HSA Registration Number: DE0506177
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The VITRA 689 ophthalmic laser photoactivator and the HS BM/BQTM slit lamp adaptors are intended to be a light source for photo-activation of the light activated drug VISUDYNEยฎ (verteporfin for injection) in photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0506177
Registration Date
September 14, 2021
Change Notification Approval Date
July 05, 2022
Retention Due Date
September 13, 2025
Product Owner
Short Name
Quantel Medical
Address
1, rue du bois joli, CS 40015, 63808 Cournon dโ€™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 689
Model Identifier(s)
PABX0051C