Pure Global

Datascope SENSATION PLUS Intra-aortic Balloon Catheter - HSA Registration DE0507089

Access comprehensive regulatory information for Datascope SENSATION PLUS Intra-aortic Balloon Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507089 and owned by Datascope Corp. The device was registered on July 15, 2022.

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 D
DE0507089
Datascope SENSATION PLUS Intra-aortic Balloon Catheter
HSA Registration Number: DE0507089
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The intra-aortic balloon catheter and accessories are used to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0507089
Registration Date
July 15, 2022
Change Notification Approval Date
October 23, 2024
Retention Due Date
July 14, 2025
Product Owner
Short Name
Datascope
Address
15 Law Drive, Fairfield, NJ 07004, UNITED STATES
Registrant
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Address
20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model Information
Model Name(s)
SENSATION PLUS 7.5Fr. 40cc SENSATION PLUS 8Fr. 50cc SENSATION PLUS 7.5Fr. 40cc Insertion Kit ONLY SENSATION PLUS 8Fr. 50cc Insertion Kit ONLY
Model Identifier(s)
0684-00-0568-01 0684-00-0576-01 0884-00-0019-22 0884-00-0019-23