Pure Global
Singapore HSA registration DE0501153

Medimaging RetinaVue 100 Imager

Singapore flagSingapore·CLASS B·Medimaging Integrated Solution Inc.·Registered January 25, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0501153
Registration Date
January 25, 2018
Change Notification Approval Date
February 15, 2021
Retention Due Date
January 24, 2026
Product description
The Welch Allyn RetinaVue 100 Imager is a digital hand-held eye-fundus camera used to record digital photographs of the fundus (including retina, macula and optic disc) of the human eye and surrounding area.
Product Owner
Name
Medimaging Integrated Solution Inc.
Short Name
Medimaging Integrated Solution Inc.
Address
3F, No.24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, 30077, TAIWAN
Registrant
Name
Welch Allyn Singapore Pte. Ltd.
Address
1 YISHUN AVENUE 7, SINGAPORE 768923
Importer
Name
OPHTHALMIC INSTRUMENTS (PTE. LTD.) WELCH ALLYN SINGAPORE PTE. LTD.
Address
65 UBI ROAD 1, OXLEY BIZHUB, #03-74, SINGAPORE 408729 1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923
Model information
Model Name(s)
RetinaVue 100 Charging Dock RetinaVue 100 Reusable Eye Cups RetinaVue 100 Lithium-Ion Battery Welch Allyn RetinaVue Network Software RETINAVUE100 IMAGER SET, US PLUG RETINAVUE100 IMAGER PRO SET, US PLUG
Model Identifier(s)
106401 106404 106405 901108 RV100-B RV100PRO-B
About this record

Access comprehensive regulatory information for Medimaging RetinaVue 100 Imager in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501153 and owned by Medimaging Integrated Solution Inc.. The device was registered on January 25, 2018.

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