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MAQUET QUADROX-i System - HSA Registration DE0010583

Access comprehensive regulatory information for MAQUET QUADROX-i System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010583 and owned by Maquet Cardiopulmonary GmbH. The device was registered on September 10, 2012.

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 B
DE0010583
MAQUET QUADROX-i System
HSA Registration Number: DE0010583
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Product Description

The QUADROX-i is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Venous Hardshell Reservoir is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDB00110
HS Code
84212910
Registration Information
Registration Number
DE0010583
Registration Date
September 10, 2012
Change Notification Approval Date
November 01, 2021
Retention Due Date
September 09, 2025
Product Owner
Short Name
Maquet Cardiopulmonary GmbH
Address
Kehler Str. 31, Rastatt 76437, 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)
Holder for Oxygenator Holder for oxygenator Holder Short for HKH 7000 Basic Holder for VKMO Premium holder Holder for VKMO/VHK 70000/71000 QUADROX-I Small Adult QUADROX-I Small Adult QUADROX-I Adult QUADROX-I Adult Venous Hardshell Cardiotomy Reservoir Venous Hardshell Cardiotomy Reservoir Vacuum Tight Quadrox-i Small Adult HMO 50000+VHK 71000 Quadrox-i Small Adult HMO 51000+VHK 71000 Quadrox-i Adult HMO 70000 + VHK 71000 Quadrox-i Adult HMO 70000 + VHK 70000
Model Identifier(s)
016061 016062 HKH 1100 HKH 3050 HKH 7000 HMO 50000 HMO 51000 HMO 70000 HMO 71000 VHK 70000 VHK 71000 VKMO 50000 VKMO 51000 VKMO 70000 VKMO 78000