Pure Global
Singapore HSA registration DE0003545

Reichert Tono-Pen® Applanation Tonometer

Singapore flagSingapore·CLASS B·Reichert Inc.·Registered May 10, 2006
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0003545
Registration Date
May 10, 2006
Change Notification Approval Date
January 23, 2025
Retention Due Date
December 31, 2025
Product description
Intended to be used for measuring intraoccular pressure (IOP) as a screening or monitoring tool for glaucoma or when increased IOP is suspected.
Product Owner
Name
Reichert Inc.
Short Name
Reichert Inc.
Address
3362 Walden Avenue, Suite 100,Depew, NY, 14043, United States of America, TEL: +1 716 686 4568, Contact person: Elizabeth Schultz [Manager Regulatory Affairs], TEL: +1 716 686 4568 l MOBILE: +1 716 327 1837 |, elizabeth.schultz@ametek.com, UNITED STATES
Registrant
Name
EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Model information
Model Name(s)
OCU-CEL TONO-PEN AVIA POWERCEL Battery Pack TONO-PEN AVIA OCU-FILM + Tip Covers OCU-FILM + Tip Covers
Model Identifier(s)
230570 230577 230650 230651 230653
About this record

Access comprehensive regulatory information for Reichert Tono-Pen® Applanation Tonometer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0003545 and owned by Reichert Inc.. The device was registered on May 10, 2006.

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