Singapore HSA registration DE0510428
Optos OCT Ophthalmoscope P200TxE
Singapore·CLASS B·OPTOS PLC·Registered March 06, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0510428
- Registration Date
- March 06, 2025
- Retention Due Date
- March 05, 2026
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, wide field, 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
- 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 - P200TxE
- Model Identifier(s)
- A10688/A10913 A14898 P200TxE
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 DE0510428 and owned by OPTOS PLC. The device was registered on March 06, 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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