Singapore HSA registration DE0008212
Draeger Medical Infant Transport Incubator 500
Singapore·CLASS C·Draeger Medical Systems, Inc.·Registered January 05, 2012Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
- HSA Product Code
- HSAMDC00104
- HS Code
- 90189030
Registration information
- Registration Number
- DE0008212
- Registration Date
- January 05, 2012
- Change Notification Approval Date
- February 20, 2018
- Retention Due Date
- January 04, 2026
Product description
The Isolette® T1500 Transport System is intended for transport of high risk, premature, low birth weight or critically ill newborns. It provides a means to control air temperature, oxygen concentrations and add relative humidity.
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)
- SoftBed TI500 Iris port sleeve, disposable, 100 pcs. Replacement filter, 6 pcs. Humidity pad, antibacterial, 25 pcs. Mattress, 10 pcs. Mattress, 10 pcs. Restraint strap, 10 pcs. Neat-Clips, adhesive, 10 pcs. Neat-Clips, adhesive, 10 pcs Neat-Clips, adhesive, 100 pcs. Neat-Clips, adhesive, 100 pcs Access port cuff, oval, disposable, 100 pcs. Skin temperature probe 1, reusable O2 hood, oxydome Rechargeable battery, 12V TI500 Transport Incubator
- Model Identifier(s)
- MP01419 MU03876 MU04472 MU06008 MU06009 MU06010 MU06011 MU06558 MU06560 MU06562 MU06563 MU06570 MU06951 MU08394 MU16052 MU20505
About this record
Access comprehensive regulatory information for Draeger Medical Infant Transport Incubator 500 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0008212 and owned by Draeger Medical Systems, Inc.. The device was registered on January 05, 2012.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C