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PULSION PiCCO Monitoring Kit and accessories - HSA Registration DE0007191

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.

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CLASS D
DE0007191
PULSION PiCCO Monitoring Kit and accessories
HSA Registration Number: DE0007191
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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.

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 Owner
Short Name
Pulsion Medical Systems SE
Address
Hans-Riedl-Straฮฒe 17, 85622 Feldkirchen, GERMANY
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)
Inline Sensor Cable Arterial connection cable Pressure transducer Cable Inline Sensor PiCCO Monitoring Kit
Model Identifier(s)
PC80109 PC80150 PMK-206 PV4046 PV8215