Singapore HSA registration DE0510458
OCT Ophthalmoscope - P200TE
Singapore·CLASS B·OPTOS PLC·Registered March 12, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0510458
- Registration Date
- March 12, 2025
- Retention Due Date
- March 11, 2026
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 high resolution, 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. It 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
- VITOP PTE.LTD.
- Address
- 15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Importer
- Name
- VITOP PTE.LTD.
- Address
- 15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Model information
- Model Name(s)
- Image Server Touchscreen 15'' OCT Ophthalmoscope - P200TE
- Model Identifier(s)
- A10688/A10913 A14898 P200TE
About this record
Access comprehensive regulatory information for OCT 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 DE0510458 and owned by OPTOS PLC. The device was registered on March 12, 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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