Singapore HSA registration DE0015941
Pulsion PulsioFlex
Singapore·CLASS C·Pulsion Medical Systems SE·Registered July 11, 2014Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0015941
- Registration Date
- July 11, 2014
- Change Notification Approval Date
- October 11, 2024
- Retention Due Date
- July 10, 2025
Product description
The use of the PulsioFlex is indicated in at risk patients undergoing surgical interventions where cardiovascular monitoring is necessary. It is indicated in patients in Recovery Rooms/Step Down Units, High Dependency/Intermediate Care Units, A&E/Emergency Departments, Surgical, Medical, Burn, Trauma and other units/areas where blood pressure and/or cardiac output trend monitoring is necessary (ProAQT). Continuous monitoring of central venous oxygen saturation (CeVOX) is indicated in all intensive care patients particularly in cases of sepsis and multi-organ failure; management of early goal directed therapy in severe sepsis; Cardiogenic Shock and Cardiopulmonary Resuscitation. The Indocyanine Green concentration and elimination measurement is indicated in all patients with persistent or expected limitations of their global liver function (cellular function or perfusion) and/or splanchnic perfusion (LiMON).
Product Owner
- Short Name
- Pulsion Medical Systems SE
- Address
- Hans-Riedl-Straβe 17, 85622 Feldkirchen, GERMANY
Registrant
- Address
- 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
- Address
- 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914 6 TAGORE DRIVE, TAGORE BUILDING, #04-11, SINGAPORE 787623
Model information
- Model Name(s)
- CeVOX Module PulsioFlex Haemodynamic Monitoring Platform PiCCO Module ProAQT Sensor Cable LiMON Sensor LiMON Module ProAQT Sensor
- Model Identifier(s)
- PC3040 PC4000 PC4510 PC45810-300 PC51200 PC5140 PV8810
About this record
Access comprehensive regulatory information for Pulsion PulsioFlex in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0015941 and owned by Pulsion Medical Systems SE. The device was registered on July 11, 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.
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