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OPTOS PANORAMIC OPHTHALMOSCOPE DAYTONA (P200T) - HSA Registration DE0011412

Access comprehensive regulatory information for OPTOS 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 DE0011412 and owned by OPTOS PLC. The device was registered on October 22, 2012.

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
DE0011412
OPTOS PANORAMIC OPHTHALMOSCOPE DAYTONA (P200T)
HSA Registration Number: DE0011412
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Product Description

The P200T scanning laser ophthalmoscope is intended to be used as a wide field 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
DE0011412
Registration Date
October 22, 2012
Change Notification Approval Date
April 03, 2024
Retention Due Date
October 21, 2025
Product Owner
Short Name
OPTOS PLC
Address
Queensferry House,Carnegie Business, Campus,Queensferry Road,, Dunfermline,, Fife KY11 8GR, UNITED KINGDOM
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)
Panoramic Ophthalmoscope
Model Identifier(s)
P200T