Singapore HSA registration DE0015799
Agfa Healthcare IMPAX Heartstation 1.7
Singapore·CLASS B·Agfa Healthcare N.V.·Registered June 30, 2014Device 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 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.
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
About this record
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 DatabasePowered by Pure Global AIHSA Official DataCLASS B