Singapore HSA registration DE0504353
Draeger Atlan A300 Series
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Anaesthesiology
Registration information
- Registration Number
- DE0504353
- Registration Date
- April 09, 2020
- Change Notification Approval Date
- June 07, 2024
- Retention Due Date
- April 08, 2026
Product description
This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions: – Ventilation monitoring – Inspiratory O2 measurement – Device monitoring – Anesthetic gas receiving system The following options are additionally available: – Patient-gas measurement module for O2, CO2, N2O, and anesthetic gases – O2 insufflation
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)
- Atlan A300 Atlan A300 XL
- Model Identifier(s)
- 8621300 8621400
About this record
Access comprehensive regulatory information for Draeger Atlan A300 Series in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504353 and owned by Dragerwerk AG & Co. KGaA. The device was registered on April 09, 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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