Singapore HSA registration DE0017634
Smiths Medical Portex Percutaneous Dilatation Tracheostomy Kit
Singapore·CLASS B·Smiths Medical ASD, Inc.·Registered November 11, 2015Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Anaesthesiology
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90192000
Registration information
- Registration Number
- DE0017634
- Registration Date
- November 11, 2015
- Change Notification Approval Date
- May 11, 2021
- Retention Due Date
- November 10, 2025
Product description
Intended for controlled, elective subcricoid precutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique
Product Owner
- Short Name
- Smiths Medical ASD, Inc.
- Address
- 6000 Nathan Lane N., Minneapolis, MN 55442, UNITED STATES
Registrant
- Address
- 1 KALLANG JUNCTION, Vanguard Campus, #01-23/25, SINGAPORE 339263
Importer
- Address
- 1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model information
- Model Name(s)
- Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for 7,8 & 9mm Tubes Only. Without Tracheostomy Tube
- Model Identifier(s)
- 100/562/000
About this record
Access comprehensive regulatory information for Smiths Medical Portex Percutaneous Dilatation Tracheostomy Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017634 and owned by Smiths Medical ASD, Inc.. The device was registered on November 11, 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.
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