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Singapore HSA registration DE0017350

Centervue Eidon

Singapore flagSingapore·CLASS B·CENTERVUE SPA·Registered July 24, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0017350
Registration Date
July 24, 2015
Change Notification Approval Date
April 17, 2025
Retention Due Date
July 23, 2025
Product description
EIDON is intended for taking digital images of a human retina without the use of a mydriatic agent. EIDON is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal images of the retina. Multiple retinal fields can be captured using a programmable internal fixation target. The device integrates a tablet and is provided with an external power supply. The device works with a dedicated software application and operates as a standalone unit. In addition to the Eidon features, Eidon AF can take blue fundus autofluorescence retinal images.
Product Owner
Name
CENTERVUE SPA
Short Name
CENTERVUE SPA
Address
San Marco 9H 35129, ITALY
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)
Eidon Eidon AF
Model Identifier(s)
Eidon Eidon AF
About this record

Access comprehensive regulatory information for Centervue Eidon in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017350 and owned by CENTERVUE SPA. The device was registered on July 24, 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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