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Singapore HSA registration DE0505263

Optos OCT Ophthalmoscope P200TxE

Singapore flagSingapore·CLASS B·Optos Plc·Registered December 23, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0505263
Registration Date
December 23, 2020
Retention Due Date
December 22, 2025
Product description
The P200TxE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo digital imaging of posterior ocular structures, including the vitro-retinal interface, retina, retinal layers, optic disc, choroid and choroido-scleral interface. It is indicated for producing high-resolution, widefield, en-face reflectance images, auto fluorescence images, fluorescein angiography images, indocyanine green angiography images, and axial cross-sectional images of the posterior ocular structures. The system enables practitioners to capture multi-modal images in support of detection, investigation and monitoring of retinal conditions.
Product Owner
Name
Optos Plc
Short Name
Optos Plc
Address
Queensferry House, Carnegie Campus,, Enterprise Way, Dunfermline, Fife KY11 8GR, UNITED KINGDOM
Registrant
Name
OPHTHALMIC INSTRUMENTS (PTE. LTD.)
Address
65 UBI ROAD 1, OXLEY BIZHUB, #03-74, SINGAPORE 408729
Importer
Name
OPHTHALMIC INSTRUMENTS (PTE. LTD.)
Address
65 UBI ROAD 1, OXLEY BIZHUB, #03-74, SINGAPORE 408729
Model information
Model Name(s)
Touch Screen Optos Advance image server Hand control OCT Ophthalmoscope - P200TxE Touch Screen
Model Identifier(s)
A10612 A10688 A10732 A10750 A10792
About this record

Access comprehensive regulatory information for Optos OCT Ophthalmoscope P200TxE in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505263 and owned by Optos Plc. The device was registered on December 23, 2020.

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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