Singapore HSA registration DE0506100
Quantel Medical Optimis Fusion SLT/YAG laser
Singapore·CLASS C·Quantel Medical·Registered August 24, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0506100
- Registration Date
- August 24, 2021
- Change Notification Approval Date
- July 05, 2022
- Retention Due Date
- August 23, 2025
Product description
The OPTIMIS FUSION incorporates two treatment modes and is intended for: - YAG photodisruption mode — to carry out: • posterior capsulotomy • iridotomy • posterior membranectomy - SLT mode — to carry out: • selective Laser Trabeculoplasty (SLT)
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)
- Optimis Fusion
- Model Identifier(s)
- FUSION
About this record
Access comprehensive regulatory information for Quantel Medical Optimis Fusion SLT/YAG laser in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506100 and owned by Quantel Medical. The device was registered on August 24, 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.
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