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VISIONIX HANDHELD AUTO REFRACTOMTER RETINOMAX SERIES - HSA Registration DE0510494

Access comprehensive regulatory information for VISIONIX HANDHELD AUTO REFRACTOMTER RETINOMAX SERIES in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510494 and owned by LUNEAU TECHNOLOGY OPERATIONS SAS. The device was registered on March 24, 2025.

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
DE0510494
VISIONIX HANDHELD AUTO REFRACTOMTER RETINOMAX SERIES
HSA Registration Number: DE0510494
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Product Description

This product is an objective refractometer offering capabilities of measuring refractive power, corneal shape, and pupil diameter.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510494
Registration Date
March 24, 2025
Retention Due Date
March 23, 2026
Product Owner
Short Name
LUNEAU TECHNOLOGY OPERATIONS SAS
Address
2 Rue Roger Bonnet, 27340 Pont-de-l'Arche, FRANCE
Registrant
Address
65 UBI ROAD 1, OXLEY BIZHUB, #03-74, SINGAPORE 408729
Importer
Address
65 UBI ROAD 1, OXLEY BIZHUB, #03-74, SINGAPORE 408729
Model Information
Model Name(s)
Retinomax 5 Retinomax 5 Retinomax K-plus 5 Retinomax K-plus 5 Retinomax Screeen Retinomax Screeen Retinomax K+Sceeen Retinomax K+Screeen
Model Identifier(s)
VSN5100BG VSN5100TG VSN5200BG VSN5200TG VSN5300BG VSN5300TG VSN5400BG VSN5400TG