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Singapore HSA registration DE0012338

Smiths Medical Portex Percutaneous Dilatation Tracheostomy Kit, with Suctionaid

Singapore flagSingapore·CLASS C·Smiths Medical ASD, Inc.·Registered February 13, 2013
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0012338
Registration Date
February 13, 2013
Change Notification Approval Date
May 26, 2020
Retention Due Date
February 12, 2026
Product description
Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique. Suctionaid allows aspiration of contaminated mucous and subglottic secretions that collect and build up between the Tracheostomy tube cuff and the glottis.
Product Owner
Name
Smiths Medical ASD, Inc.
Short Name
Smiths Medical ASD, Inc.
Address
6000 Nathan Lane N., Minneapolis, MN 55442, UNITED STATES
Registrant
Name
IDS MEDICAL SYSTEMS
Address
1 KALLANG JUNCTION, Vanguard Campus, #01-23/25, SINGAPORE 339263
Importer
Name
IDS MEDICAL SYSTEMS (SINGAPORE) PTE LTD
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model information
Model Name(s)
Portex Percutaneous Dilation Kit with Blue Line Ultra Suctionaid Tracheostomy Tube Portex Percutaneous Dilation Kit with Blue Line Ultra Suctionaid Tracheostomy Tube Portex Percutaneous Dilation Kit with Blue Line Ultra Suctionaid Tracheostomy Tube
Model Identifier(s)
100/563/070 100/563/080 100/563/090
About this record

Access comprehensive regulatory information for Smiths Medical Portex Percutaneous Dilatation Tracheostomy Kit, with Suctionaid in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0012338 and owned by Smiths Medical ASD, Inc.. The device was registered on February 13, 2013.

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