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Singapore HSA registration DE0506177

Quantel Medical Vitra 689

Singapore flagSingapore·CLASS C·Quantel Medical·Registered September 14, 2021
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 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 VISUDYNE® (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.
Product Owner
Name
Quantel Medical
Short Name
Quantel Medical
Address
1, rue du bois joli, CS 40015, 63808 Cournon d’Auvergne Cedex, FRANCE
Registrant
Name
Transmedic Pte Ltd
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
Name
SWISSMED PTE LTD TRANSMEDIC PTE LTD
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
About this record

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 DatabasePowered by Pure Global AIHSA Official DataCLASS C