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Singapore HSA registration DE0508874

Shanghai MediWorks Precision Instruments Automatic fundus camera

Singapore flagSingapore·CLASS B·Shanghai MediWorks Precision Instruments Co., Ltd.·Registered January 22, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0508874
Registration Date
January 22, 2024
Change Notification Approval Date
July 04, 2024
Retention Due Date
January 21, 2026
Product description
The automatic fundus camera is intended to enable automatically capturing the images of human fundus, without dilating patient’s pupils. The automatic fundus camera is intended for use in eye inspection of the fundus, for example, retina related disease examination. The captured colorful fundus images can provide the evidence to the ophthalmologist for diagnosis purpose. The device can be applied to inspect the adults and the children.
Product Owner
Name
Shanghai MediWorks Precision Instruments Co., Ltd.
Short Name
Shanghai MediWorks Precision Instruments Co., Ltd.
Address
No.7, MingPu Phase Ⅱ, No. 3279 SanLu Road, MinHang District 201100, Shanghai, CHINA
Registrant
Name
EYRIS PTE. LTD.
Address
60 MACPHERSON ROAD, BLOCK 1 SIEMENS CENTRE, #05-08, SINGAPORE 348615
Importer
Name
MEDTECHBOSS PTE. LTD. OPHTHALMIC INSTRUMENTS (PTE. LTD.)
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #02-08, SINGAPORE 159557 65 UBI ROAD 1, OXLEY BIZHUB, #03-74, SINGAPORE 408729
Model information
Model Name(s)
Automatic fundus camera
Model Identifier(s)
FC162
About this record

Access comprehensive regulatory information for Shanghai MediWorks Precision Instruments Automatic fundus camera in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508874 and owned by Shanghai MediWorks Precision Instruments Co., Ltd.. The device was registered on January 22, 2024.

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