Singapore HSA registration DE0510239
Xenios Nova lung Kits
Singapore·CLASS D·Xenios AG·Registered January 15, 2025Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510239
- Registration Date
- January 15, 2025
- Retention Due Date
- January 14, 2026
Product description
The Novalung kits are intended to be part of the Xenios system for prolonged (up to 29 days) respiratory/cardiopulmonary life support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the blood.
Product Owner
- Name
- Xenios AG
- Short Name
- Xenios AG
- Address
- Im Zukunftspark 1, Heilbronn 74076, GERMANY
Registrant
- Address
- 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Importer
- Address
- 238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Model information
- Model Name(s)
- MiniLung kit 1/4" MiniLung petite kit XLung kit 230
- Model Identifier(s)
- 32000001 32000003 32000014
About this record
Access comprehensive regulatory information for Xenios Nova lung Kits in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510239 and owned by Xenios AG. The device was registered on January 15, 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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