Singapore HSA registration DE0508757
NIDEK Optical Biometer AL-Scan M
Singapore·CLASS B·NIDEK CO., LTD·Registered December 14, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0508757
- Registration Date
- December 14, 2023
- Change Notification Approval Date
- February 26, 2025
- Retention Due Date
- December 13, 2025
Product description
The Optical Biometer AL-Scan M is a medical device that optically measures eye components such as corneal curvature radius, and axial length.
Product Owner
- Name
- NIDEK CO., LTD
- Short Name
- NIDEK CO., LTD
- Address
- 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, JAPAN
Registrant
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, SIGNATURE, THE, #06-14, SINGAPORE 486066
Importer
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, SIGNATURE, THE, #06-14, SINGAPORE 486066 6 UBI ROAD 1, WINTECH CENTRE, #03-12, SINGAPORE 408726
Model information
- Model Name(s)
- Optical Biometer Myopia Viewer
- Model Identifier(s)
- AL-Scan M MV-1
About this record
Access comprehensive regulatory information for NIDEK Optical Biometer AL-Scan M in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508757 and owned by NIDEK CO., LTD. The device was registered on December 14, 2023.
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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