Singapore HSA registration DE0017912
Smiths Medical Bivona® Cuffless Adult Tracheostomy Tubes
Singapore·CLASS C·Smiths Medical ASD, Inc.·Registered March 01, 2016Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
- HSA Product Code
- HSAMDC00102
- HS Code
- 90183990
Registration information
- Registration Number
- DE0017912
- Registration Date
- March 01, 2016
- Change Notification Approval Date
- October 22, 2020
- Retention Due Date
- February 28, 2026
Product description
This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient reuse.
Product Owner
- Short Name
- Smiths Medical ASD, Inc.
- Address
- 6000 Nathan Lane North, Minneapolis MN 55442, UNITED STATES
Registrant
- Address
- 1 KALLANG JUNCTION, Vanguard Campus, #05-01, SINGAPORE 339263
Importer
- Address
- 1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model information
- Model Name(s)
- Adult Tracheostomy Tube, Cuffless Adult Tracheostomy Tube, Cuffless Adult Tracheostomy Tube, Cuffless Adult Tracheostomy Tube, Cuffless Adult Tracheostomy Tube, Cuffless
- Model Identifier(s)
- 60A150 60A160 60A170 60A180 60A190
About this record
Access comprehensive regulatory information for Smiths Medical Bivona® Cuffless Adult Tracheostomy Tubes in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017912 and owned by Smiths Medical ASD, Inc.. The device was registered on March 01, 2016.
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