Singapore HSA registration DE0504833
Draeger Evita V800/ Evita V600 Intensive Care Ventilator
Singapore·CLASS C·Dragerwerk AG & Co. KGaA·Registered August 19, 2020Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0504833
- Registration Date
- August 19, 2020
- Change Notification Approval Date
- April 02, 2025
- Retention Due Date
- August 18, 2025
Product description
The intensive care ventilator Evita is intended for the ventilation of adults, pediatric patients and neonates. 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
- Short Name
- Dragerwerk AG & Co. KGaA
- Address
- Moislinger Allee 53-55, 23542 Lubeck, GERMANY
Registrant
- Address
- 61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Importer
- Address
- 61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Model information
- Model Name(s)
- Evita V600 Evita V800
- Model Identifier(s)
- 8422300 8422500
About this record
Access comprehensive regulatory information for Draeger Evita V800/ Evita V600 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 DE0504833 and owned by Dragerwerk AG & Co. KGaA. The device was registered on August 19, 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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