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Panoramic Ophthalmoscope - Daytona (P200T) - HSA Registration DE0510477

Access comprehensive regulatory information for Panoramic Ophthalmoscope - Daytona (P200T) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510477 and owned by OPTOS PLC. The device was registered on March 19, 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
DE0510477
Panoramic Ophthalmoscope - Daytona (P200T)
HSA Registration Number: DE0510477
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Product Description

The P200T scanning laser ophthalmoscope is intended to be used as a widefield and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510477
Registration Date
March 19, 2025
Retention Due Date
March 18, 2026
Product Owner
Short Name
OPTOS PLC
Address
Queensferry House, Carnegie Campus,, Enterprise Way Dunfermline, Fife, KY11 8GR, UNITED KINGDOM
Registrant
Address
15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Importer
Address
15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Model Information
Model Name(s)
Image Server Touchscreen 15'' Panoramic Ophthalmoscope - Daytona (P200T) Panoramic Ophthalmoscope - P200T UWF Primary
Model Identifier(s)
A10688/A10913 A14898 P200T P200T UWFp