Singapore HSA registration DE0008492
Datascope Mega Intra-aortic Balloon Catheter
Singapore·CLASS D·Datascope Corp·Registered February 20, 2012Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- HSAMDD00110
- HS Code
- 90183910
Registration information
- Registration Number
- DE0008492
- Registration Date
- February 20, 2012
- Change Notification Approval Date
- October 23, 2024
- Retention Due Date
- February 19, 2026
Product description
Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon 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)
- Adult Safety Chamber J3FC-SS 145-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 145cm PTFE Coated (Type L) Stainless Steel J3FC-SS 175-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 175cm PTFE Coated (Type L) Stainless Steel J3FC-SS 260-025, Sterile Pouched Guide Wire .025”(+0,/-.001”) x 260cm PTFE Coated (Type L) Stainless Steel Catheter Extender for MEGA 7.5Fr. 30 & 40cc IAB's ONLY MEGA 7.5 Fr. 30cc IAB Catheter with STATLOCK MEGA 7.5Fr. 30cc IAB Catheter with STATLOCK MEGA 7.5Fr. 40cc IAB Catheter with STATLOCK MEGA 7.5Fr. 40cc IAB Catheter with STATLOCK MEGA 8Fr. 50cc IAB Catheter with STATLOCK MEGA 8Fr. 50cc IAB Catheter with STATLOCK REINFORCED INTRODUCER SET With Hemostasis Valve For use with MAQUET 7.5Fr. IAB REINFORCED INTRODUCER SET With Hemostasis Valve For use with MAQUET 8Fr. IAB Mega 50 8 Fr. 50cc Mega 50 8 Fr. 50cc Arrow Pump Adapter Arrow Pump Adapter For use with MEGA 8Fr. 50cc IAB Only Catheter Extender For MEGA 8Fr. 50cc IAB ONLY Insertion Kit with 6” (15cm) Introducer for use with Mega 8 Fr. 50cc IAB Insertion Kit with 7.5Fr 6" (15cm) Introducer for use with MEGA 7.5Fr 30 &40 cc IABs
- Model Identifier(s)
- 0683-00-0187 0684-00-0254-09 0684-00-0254-14 0684-00-0254-15 0684-00-0275 0684-00-0294-01 0684-00-0294-02 0684-00-0295-01 0684-00-0295-02 0684-00-0296-01 0684-00-0296-02 0684-00-0403-05 0684-00-0403-10 0684-00-0498-01 0684-00-0498-02 0684-00-0510-01 0684-00-0510-02 0684-00-0526 0884-00-0019-17 0884-00-0019-21
About this record
Access comprehensive regulatory information for Datascope Mega 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 DE0008492 and owned by Datascope Corp. The device was registered on February 20, 2012.
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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