Pure Global
Singapore HSA registration DE0017323

Welch Allyn Spot Vision Screener

Singapore flagSingapore·CLASS B·Welch Allyn Inc.·Registered July 15, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0017323
Registration Date
July 15, 2015
Change Notification Approval Date
December 14, 2023
Retention Due Date
July 14, 2025
Product description
The Spot Vision Screener is intended to produce optical images that can help identify refractive errors and ocular misalignments by detecting special light reflexes from each eye during screening. The Spot Vision Screener evaluates these light reflexes from the retina to estimate refractive error. It also estimates pupil size, pupil distance and eye gaze deviation. It is intended for use on subjects six months of age through adults.
Product Owner
Name
Welch Allyn Inc.
Short Name
Welch Allyn Inc.
Address
4341 State Street Road, Skaneateles Falls, NY 13153-0220, UNITED STATES
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)
Welch Allyn Spot Vision Screener
Model Identifier(s)
901029 Vision Screener
About this record

Access comprehensive regulatory information for Welch Allyn Spot Vision Screener in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017323 and owned by Welch Allyn Inc.. The device was registered on July 15, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B