Singapore HSA registration DE0510479
Panoramic Ophthalmoscope - P200DTx
Singapore·CLASS B·OPTOS PLC·Registered March 19, 2025Device 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 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.
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'' Panoramic Ophthalmoscope - P200DTx
- Model Identifier(s)
- A10688/A10913 A14898 P200DTx
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B