Pure Global

Agfa Healthcare IMPAX Heartstation 1.7 - HSA Registration DE0015799

Access comprehensive regulatory information for Agfa Healthcare IMPAX Heartstation 1.7 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0015799 and owned by Agfa Healthcare N.V.. The device was registered on June 30, 2014.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0015799
Agfa Healthcare IMPAX Heartstation 1.7
HSA Registration Number: DE0015799
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The IMPAX HeartStation® ECG Management System is a comprehensive data management solution that automates the processing, storage, and display of electrocardiograms (ECGs) and cardiac reports throughout a healthcare enterprise.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0015799
Registration Date
June 30, 2014
Change Notification Approval Date
March 24, 2016
Retention Due Date
June 29, 2025
Product Owner
Short Name
Agfa Healthcare N.V.
Address
Septestraat 27,, 2640 Mortsel, BELGIUM
Registrant
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734
Importer
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734
Model Information
Model Name(s)
IMPAX Heartstation
Model Identifier(s)
1.7