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NIDEK Optical Biometer AL-Scan M - HSA Registration DE0508757

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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CLASS B
DE0508757
NIDEK Optical Biometer AL-Scan M
HSA Registration Number: DE0508757
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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.

Device 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 Owner
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