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NIDEK AUTO REFRACTOMETER AR-F - HSA Registration DE0503222

Access comprehensive regulatory information for NIDEK AUTO REFRACTOMETER AR-F in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503222 and owned by NIDEK CO., LTD. The device was registered on June 11, 2019.

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
DE0503222
NIDEK AUTO REFRACTOMETER AR-F
HSA Registration Number: DE0503222
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Product Description

The AUTO REFRACTOMETER AR-F is a medical device which measures objective refractive errors of the patient's eye. This device also offers retroillumination mode for observing the condition of the ocular media, and measures the amplitude of accommodation.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0503222
Registration Date
June 11, 2019
Change Notification Approval Date
February 26, 2025
Retention Due Date
June 10, 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)
AUTO REFRACTOMETER Hand-held control (Wired type)
Model Identifier(s)
AR-F Hand-held control (wired type)