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Singapore HSA registration DE0007191

PULSION PiCCO Monitoring Kit and accessories

Singapore flagSingapore·CLASS D·Pulsion Medical Systems SE·Registered July 04, 2011
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0007191
Registration Date
July 04, 2011
Change Notification Approval Date
April 02, 2025
Retention Due Date
July 03, 2025
Product description
The single use pressure monitoring kit is intended for detection and measurement of blood pressure through indwelling vascular catheters providing a direct uninterrupted access to the intravascular space. The pressure monitoring kit includes a pressure transducer with an integrated flush device (flow rate: 3 ml/h with the infusion bag having a 300 mmHg pressure), an integrated locking valve, a 150 cm extension tubing, a non-vented drip chamber, a roll clip and an additional 3-way stopcock. The instructions presume that the products used are in perfect working condition.
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)
Inline Sensor Cable Arterial connection cable Pressure transducer Cable Inline Sensor PiCCO Monitoring Kit
Model Identifier(s)
PC80109 PC80150 PMK-206 PV4046 PV8215
About this record

Access comprehensive regulatory information for PULSION PiCCO Monitoring Kit and accessories in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0007191 and owned by Pulsion Medical Systems SE. The device was registered on July 04, 2011.

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 D