Singapore HSA registration DE0011352
MAQUET QUADROX-I Hallow Fiber Oxygenator Microporous Membrane
Singapore·CLASS B·Maquet Cardiopulmonary GmbH·Registered October 12, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- HSAMDB00102
- HS Code
- 84212910
Registration information
- Registration Number
- DE0011352
- Registration Date
- October 12, 2012
- Change Notification Approval Date
- November 01, 2021
- Retention Due Date
- October 11, 2025
Product description
Intended for use in an extracorporeal perfusion system. Within the stated flow rates the device oxygenates the blood, remove carbon dioxide and regulates the blood temperature.
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)
- Holding Clamp for Oxygenator Premium holder for VKMO 10000/ 11000/ 30000/ 31000 Reservoir holding bracket for premium holder Holder for individual oxygenators HMO 10000/11000/30000/31000 J-mast for premium holder QUADROX-i Neonatal QUADROX-i Neonatal QUADROX-i Pediatric QUADROX-iPediatric Venous Hardshell Cardiotomy Reservoir Venous Hardshell Cardiotomy Reservoir QUADROX-i HMO 10000 + VHK 11000 QUADROX-i HMO 11000 + VHK 11000 QUADROX-i HMO 30000 + VHK 31000 QUADROX-i HMO 31000 + VHK 31000
- Model Identifier(s)
- HKH 3571 HKH 6000 HKHZ 18 HKHZ 19 HKHZ 24 HMO 10000 HMO 11000 HMO 30000 HMO 31000 VHK 11000 VHK 31000 VKMO 10000 VKMO 11000 VKMO 30000 VKMO 31000
About this record
Access comprehensive regulatory information for MAQUET QUADROX-I Hallow Fiber Oxygenator Microporous Membrane in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011352 and owned by Maquet Cardiopulmonary GmbH. The device was registered on October 12, 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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