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Singapore HSA registration DE0510056

PULSION PiCCO Catheter

Singapore flagSingapore·CLASS B·Pulsion Medical Systems SE·Registered November 20, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0510056
Registration Date
November 20, 2024
Retention Due Date
November 19, 2025
Product description
PiCCO Catheters are used as accessories for thermodilution and arterial blood pressure measurement. PiCCO Catheters shall be handled by trained health care professionals used to handling arterial lines. PiCCO Catheters are indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
Product Owner
Name
Pulsion Medical Systems SE
Short Name
Pulsion Medical Systems SE
Address
Hans-Riedl-Straβe 17, 85622 Feldkirchen, GERMANY
Registrant
Name
GETINGE SOUTH EAST ASIA PTE. LTD.
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Name
GETINGE SINGAPORE PTE. LTD. GETINGE SOUTH EAST ASIA PTE. LTD.
Address
20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model information
Model Name(s)
PiCCO Catheter 3F, 7cm PiCCO Catheter 4Fr, 8cm PiCCO Catheter 4Fr, 16cm PiCCO Catheter 4Fr, 22cm PiCCO Catheter 5Fr, 20cm
Model Identifier(s)
PV2013L07-A PV2014L08-A PV2014L16-A PV2014L22-A PV2015L20-A
About this record

Access comprehensive regulatory information for PULSION PiCCO Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510056 and owned by Pulsion Medical Systems SE. The device was registered on November 20, 2024.

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