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Singapore HSA registration DE0504629

Draeger Babylog intensive care ventilator

Singapore flagSingapore·CLASS C·Dragerwerk AG & Co. KGaA·Registered June 23, 2020
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504629
Registration Date
June 23, 2020
Change Notification Approval Date
February 10, 2025
Retention Due Date
June 22, 2025
Product description
The intensive care ventilator Babylog is intended for the ventilation of neonates 0.4kg (0.88lb) up to 10kg (22lb), pediatric patients from 5kg (11lb) up to 20kg (44lb) bodyweight. This device provides mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring. The device is used for treating patients who require temporary or longer-term respiratory support for different medical reasons.
Product Owner
Name
Dragerwerk AG & Co. KGaA
Short Name
Dragerwerk AG & Co. KGaA
Address
Moislinger Allee 53-55, 23542 Lubeck, GERMANY
Registrant
Name
DRAEGER SINGAPORE PTE LTD
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Importer
Name
DRAEGER SINGAPORE PTE LTD
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Model information
Model Name(s)
Babylog VN600 Babylog VN800
Model Identifier(s)
8422200 8422400
About this record

Access comprehensive regulatory information for Draeger Babylog intensive care ventilator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504629 and owned by Dragerwerk AG & Co. KGaA. The device was registered on June 23, 2020.

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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