Pure Global
Singapore HSA registration DE0017051

Smiths Medical Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube

Singapore flagSingapore·CLASS C·Smiths Medical ASD, Inc.·Registered April 20, 2015
Device classification
Device Class
CLASS C
Medical Speciality Area
Ear, Nose & Throat
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0017051
Registration Date
April 20, 2015
Change Notification Approval Date
June 16, 2020
Retention Due Date
April 19, 2026
Product description
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
Name
Smiths Medical ASD, Inc.
Short Name
Smiths Medical ASD, Inc.
Address
6000 Nathan Lane North, Minneapolis MN 55442, UNITED STATES
Registrant
Name
IDS MEDICAL SYSTEMS (SINGAPORE) PTE LTD
Address
1 KALLANG JUNCTION, Vanguard Campus, #05-01, SINGAPORE 339263
Importer
Name
IDS MEDICAL SYSTEMS (SINGAPORE) PTE LTD
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model information
Model Name(s)
ADULT TRACHEOSTOMY TUBE, MID RANGE AIRE-CUF ADULT TRACHEOSTOMY TUBE, MID RANGE AIRE-CUF ADULT TRACHEOSTOMY TUBE, MID RANGE AIRE-CUF ADULT TRACHEOSTOMY TUBE, MID RANGE AIRE-CUF ADULT TRACHEOSTOMY TUBE, MID RANGE AIRE-CUF
Model Identifier(s)
750150 750160 750170 750180 750190
About this record

Access comprehensive regulatory information for Smiths Medical Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017051 and owned by Smiths Medical ASD, Inc.. The device was registered on April 20, 2015.

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