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Singapore HSA registration DE0507830

Edwards Lifesciences VAMP Closed Blood Sampling Systems and Truwave Pressure Monitoring Kits

Singapore flagSingapore·CLASS B·Edwards Lifesciences LLC·Registered February 28, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0507830
Registration Date
February 28, 2023
Retention Due Date
February 28, 2026
Product description
The VAMP Adult and VAMP Plus blood sampling system is intended for patients requiring periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central catheters and central venous catheter, which are attached to pressure monitoring lines. The Pressure Monitoring Kit with TruWave disposable pressure transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Product Owner
Name
Edwards Lifesciences LLC
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Name
EDWARDS LIFESCIENCES (ASIA) PTE. LTD.
Address
238B THOMSON ROAD, NOVENA SQUARE, #18-01/08, SINGAPORE 307685
Importer
Name
EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD.
Address
35 CHANGI NORTH CRESCENT, SINGAPORE 499641
Model information
Model Name(s)
VAMP 6 in (15cm) Blood Management System VAMP 20 in (50cm) Blood Management System VAMP 60 in (150cm) Blood Management System VAMP 84 in (210cm) Blood Management System TruWave 3 cc/VAMP 60 in (150cm) Pressure Monitoring Set TruWave 3 cc/VAMP 84 in (210cm) Pressure Monitoring Set TruWave 3 cc/VAMP 60 in (150cm) Pressure Monitoring Set TruWave 3 cc/VAMP 84 in (210cm) Pressure Monitoring Set TruWave x 2 (3cc)/VAMP 63 in (160cm) Pressure Monitoring Set TruWave (3 cc)/VAMP Plus 87 in (220 cm) Pressure Monitoring Set TruWave (3cc)/VAMP Plus 60 in (150cm) Pressure Monitoring Set TruWave (3cc)/VAMP Plus 72 in (180cm) Pressure Monitoring Set TruWave (3cc)/VAMP Plus 84 in (210cm) Pressure Monitoring Set TruWave x 3 (3cc)/VAMP Plus TruWave x 3 (3cc)/VAMP Plus Pressure Monitoring Set TruWave x 2 (3 cc)/VAMP Plus Pressure Monitoring Set TruWave (3 cc)/VAMP Plus 86 in (218cm) Pressure Monitoring Set TruWave (3 cc)/VAMP Plus (215cm) Pressure Monitoring Set TruWave x 3 (3cc)/VAMP Plus (215cm) Pressure Monitoring Set TruWave x 2 (3cc)/VAMP Plus (215cm) Pressure Monitoring Set VAMP Plus 60 in (150cm) Blood Management System
Model Identifier(s)
48VMP106 48VMP120 48VMP160 48VMP284 PXVMP160 PXVMP184 PXVMP260 PXVMP284 PXVMP2X22 PXVP0034 PXVP2260 PXVP2272 PXVP2284 PXVP23X3 PXVP23X3AT3 PXVP2X2AT3 PXVPL0029 T001691M T100671M T430023M VP2
About this record

Access comprehensive regulatory information for Edwards Lifesciences VAMP Closed Blood Sampling Systems and Truwave Pressure Monitoring Kits in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507830 and owned by Edwards Lifesciences LLC. The device was registered on February 28, 2023.

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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