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Singapore HSA registration DE0507726

Covidien Chameleon™ PTA Balloon Catheter with Injection Port

Singapore flagSingapore·CLASS D·Covidien IIc·Registered January 31, 2023
Device classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0507726
Registration Date
January 31, 2023
Retention Due Date
January 30, 2026
Product description
The Chameleon™ PTA Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon™ enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
Product Owner
Name
Covidien IIc
Short Name
Covidien IIc
Address
15 Hampshire Street, Mansfield, MA 02048, UNITED STATES
Registrant
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
PTA Balloon Catheter with Injection Port 5mm x 40 mm PTA Balloon Catheter with Injection Port 6mm x 40 mm PTA Balloon Catheter with Injection Port 7mm x 40 mm PTA Balloon Catheter with Injection Port 8mm x 40 mm PTA Balloon Catheter with Injection Port 9mm x 40 mm PTA Balloon Catheter with Injection Port 10mm x 40 mm PTA Balloon Catheter with Injection Port 12mm x 40 mm
Model Identifier(s)
CH05-40-75US CH06-40-75US CH07-40-75US CH08-40-75US CH09-40-75US CH10-40-75US CH12-40-75US
About this record

Access comprehensive regulatory information for Covidien Chameleon™ PTA Balloon Catheter with Injection Port in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507726 and owned by Covidien IIc. The device was registered on January 31, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D