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Singapore HSA registration DE0503092

Optos Monaco Ophthalmoscope P200TE

Singapore flagSingapore·CLASS B·Optos Plc·Registered May 13, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0503092
Registration Date
May 13, 2019
Change Notification Approval Date
November 03, 2020
Retention Due Date
May 12, 2025
Product description
The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc. It is indicated for producing highresolution, widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps. The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.
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)
Optos P200TE Monaco Ophthalmoscope
Model Identifier(s)
P200TE
About this record

Access comprehensive regulatory information for Optos Monaco Ophthalmoscope P200TE in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503092 and owned by Optos Plc. The device was registered on May 13, 2019.

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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