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Singapore HSA registration DE0510348

Maquet Avalon Elite Bi-Caval Dual Lumen Catheter

Singapore flagSingapore·CLASS B·Maquet Cardiopulmonary GmbH·Registered February 17, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0510348
Registration Date
February 17, 2025
Retention Due Date
February 16, 2026
Product description
The Avalon Elite Bi-Caval Dual Lumen Catheter is indicated for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures. The maximum duration of use is 14 days. The device is indicated for extracorporeal life support procedures due to respiratory failure.
Product Owner
Name
Maquet Cardiopulmonary GmbH
Short Name
Maquet Cardiopulmonary GmbH
Address
Kehler Str. 31, Rastatt 76437, 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)
Avalon Elite Bi-Caval Dual Lumen Catheter 13 Fr Avalon Elite Bi-Caval Dual Lumen Catheter 16 Fr Avalon Elite Bi-Caval Dual Lumen Catheter 19 Fr Avalon Elite Bi-Caval Dual Lumen Catheter 20 Fr Avalon Elite Bi-Caval Dual Lumen Catheter 23 Fr Avalon Elite Bi-Caval Dual Lumen Catheter 27 Fr Avalon Elite Bi-Caval Dual Lumen Catheter 31 Fr
Model Identifier(s)
10013-CE 10016-CE 10019-CE 10020-CE 10023-CE 10027-CE 10031-CE
About this record

Access comprehensive regulatory information for Maquet Avalon Elite Bi-Caval Dual Lumen 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 DE0510348 and owned by Maquet Cardiopulmonary GmbH. The device was registered on February 17, 2025.

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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