Singapore HSA registration DE0503222
NIDEK AUTO REFRACTOMETER AR-F
Singapore·CLASS B·NIDEK CO., LTD·Registered June 11, 2019Device 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 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.
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)
- AUTO REFRACTOMETER Hand-held control (Wired type)
- Model Identifier(s)
- AR-F Hand-held control (wired type)
About this record
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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