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Panoramic Ophthalmoscope - P200DTx - HSA Registration DE0510479

Access comprehensive regulatory information for Panoramic Ophthalmoscope - P200DTx in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510479 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
DE0510479
Panoramic Ophthalmoscope - P200DTx
HSA Registration Number: DE0510479
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Product Description

The P200DTx scanning laser ophthalmoscope is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina. It is also indicated for use as a widefield scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using Indocyanine Green dye and for aiding in both the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510479
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 - P200DTx
Model Identifier(s)
A10688/A10913 A14898 P200DTx