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Quantel Medical Vitra PDT - HSA Registration DE0019355

Access comprehensive regulatory information for Quantel Medical Vitra PDT in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019355 and owned by Quantel Medical. The device was registered on June 23, 2017.

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
DE0019355
Quantel Medical Vitra PDT
HSA Registration Number: DE0019355
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Product Description

The VITRA PDT 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
DE0019355
Registration Date
June 23, 2017
Change Notification Approval Date
July 05, 2022
Retention Due Date
June 22, 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)
BM/BQ Haag Streit slit lamp VITRA PDT
Model Identifier(s)
XL689BMBQ XLVITRAPDT