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Xenios Nova lung Kits - HSA Registration DE0510239

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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CLASS D
DE0510239
Xenios Nova lung Kits
HSA Registration Number: DE0510239
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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.

Device 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 Owner
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