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Draeger Medical Infant Transport Incubator 500 - HSA Registration DE0008212

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.

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CLASS C
DE0008212
Draeger Medical Infant Transport Incubator 500
HSA Registration Number: DE0008212
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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.

Device 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 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