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Singapore HSA registration DE0018237

Crystalvue TonoVue

Singapore flagSingapore·CLASS B·Crystalvue Medical Corporation·Registered June 10, 2016
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0018237
Registration Date
June 10, 2016
Change Notification Approval Date
October 05, 2022
Retention Due Date
June 09, 2025
Product description
TonoVue is a non-contact tonometer that is intended to measure the intraocular pressure of human eye in vivo.
Product Owner
Name
Crystalvue Medical Corporation
Short Name
Crystalvue Medical Corporation
Address
No.116, Ln.956, Zhongshan Rd.,, Taoyuan Dist., Taoyuan City 33072,, TAIWAN
Registrant
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Importer
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Model information
Model Name(s)
TonoVue TonoVue
Model Identifier(s)
700-C0611-001 700-C0612-001
About this record

Access comprehensive regulatory information for Crystalvue TonoVue in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018237 and owned by Crystalvue Medical Corporation. The device was registered on June 10, 2016.

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