Singapore HSA registration DE0507089
Datascope SENSATION PLUS Intra-aortic Balloon Catheter
Singapore·CLASS D·Datascope Corp·Registered July 15, 2022Device 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 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.
Product Owner
- Name
- Datascope Corp
- 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
About this record
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.
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