Singapore HSA registration DE0502330
Draeger Isolette 8000 plus incubator
Singapore·CLASS C·Draeger Medical Systems, Inc.·Registered November 13, 2018Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0502330
- Registration Date
- November 13, 2018
- Retention Due Date
- November 12, 2025
Product description
The Isolette 8000 plus incubator provides a controlled environment for both premature and full-term babies up to a maximum of 10 kg (22 lb). It controls temperature, oxygen (optional), and humidity (optional).
Product Owner
- Short Name
- Draeger Medical
- Address
- 3135 Quarry Road, Telford, PA 18969, UNITED STATES
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)
- MIBII PROTO CONV-LS SoftBed C2000 MIB CBL CALEO/C2000/BABYTHM 2M IV pole assembly Isolette 8000 plus Oxygen Sensor kit Probe, yellow, central skin temperature, disposable, 10 Probe, white, peripheral skin temperature, disposable, 10
- Model Identifier(s)
- 7256931 MP01401 MS18805 MU12955 MU20602 MU24903 MU26041 MU26042
About this record
Access comprehensive regulatory information for Draeger Isolette 8000 plus incubator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502330 and owned by Draeger Medical Systems, Inc.. The device was registered on November 13, 2018.
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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