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Smiths Medical Portex Percutaneous Dilatation Tracheostomy Kit - HSA Registration DE0017634

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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CLASS B
DE0017634
Smiths Medical Portex Percutaneous Dilatation Tracheostomy Kit
HSA Registration Number: DE0017634
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Product Description

Intended for controlled, elective subcricoid precutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique

Device 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 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