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Singapore HSA registration DE0508229

Cook Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set

Singapore flagSingapore·CLASS C·Cook Incorporated·Registered June 22, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508229
Registration Date
June 22, 2023
Change Notification Approval Date
December 17, 2024
Retention Due Date
June 21, 2025
Product description
The Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g. ICU or operating room) with the assistance of trained personnel.
Product Owner
Name
Cook Incorporated
Short Name
Cook Incorporated
Address
750 Daniels Way, Bloomington Indiana 47404, USA, UNITED STATES
Registrant
Name
COOK SOUTH EAST ASIA PTE LTD
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Importer
Name
COOK SOUTH EAST ASIA PTE LTD
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Model information
Model Name(s)
Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
Model Identifier(s)
C-PTIS-100-HC-G-EU-FLEX7.5 C-PTIS-100-HC-G-EU-FLEX8.5
About this record

Access comprehensive regulatory information for Cook Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508229 and owned by Cook Incorporated. The device was registered on June 22, 2023.

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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