Singapore HSA registration DE0017301
Optos California Panoramic Ophthalmoscope
Singapore·CLASS B·OPTOS PLC·Registered July 06, 2015Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
- HSA Product Code
- HSAMDB00108
- HS Code
- 90185000
Registration information
- Registration Number
- DE0017301
- Registration Date
- July 06, 2015
- Retention Due Date
- July 05, 2025
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 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)
- Touchscreen California Workstation
- Model Identifier(s)
- A10612 P200DTx WS
About this record
Access comprehensive regulatory information for Optos California Panoramic Ophthalmoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017301 and owned by OPTOS PLC. The device was registered on July 06, 2015.
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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