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Concept Medical Research MagicTouch Sirolimus Coated Balloon Catheter - HSA Registration DE0501551

Access comprehensive regulatory information for Concept Medical Research MagicTouch Sirolimus Coated Balloon Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0501551 and owned by Concept Medical Research Pvt. Ltd. The device was registered on April 23, 2018.

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 COM
DE0501551
Concept Medical Research MagicTouch Sirolimus Coated Balloon Catheter
HSA Registration Number: DE0501551
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Product Description

Magic Touch Sirolimus Coated Balloon Catheter is indicated for treatment of Coronary Artery Disease by performing Percutaneous Transluminal Coronary Angioplasty, after appropriate lesion preparation. Sirolimus Coated Balloon Catheter is therefore indicated to dilate the diseased segment(s) in coronary artery by delivering drug in coronary artery or graft with lesion lengths of 6.00 mm to 36.00 mm and reference vessel diameter from 1.50 mm to 4.00 mm. The device is intended for use in following conditions: • Patients with de-novo lesion; • Patients with In-stent restenosis of previous stent implantation; • Patients with disease in small vessels where stent implantation is either not feasible or involving higher risk of restenosis; • Patients with bifurcation lesions.

Device Classification
Device Class
CLASS COM
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0501551
Registration Date
April 23, 2018
Change Notification Approval Date
October 01, 2024
Retention Due Date
April 22, 2026
Product Owner
Short Name
Concept Medical Research Pvt. Ltd
Address
Office 901~903, Trinnity Orion, Beside Jolly Residency, Vesu, Surat - 395 007 Gujarat, INDIA
Registrant
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Importer
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518 3 SHENTON WAY, SHENTON HOUSE, #12-08, SINGAPORE 068805
Model Information
Model Name(s)
1.50 mm x 10 mm 1.50 mm x 15 mm 1.50 mm x 20 mm 1.50 mm x 25 mm 1.50 mm x 30 mm 1.50 mm x 35 mm 1.50 mm x 40 mm 2.00 mm x 10 mm 2.00 mm x 15 mm 2.00 mm x 20 mm 2.00 mm x 25 mm 2.00 mm x 30 mm 2.00 mm x 35 mm 2.00 mm x 40 mm 2.25 mm x 10 mm 2.25 mm x 15 mm 2.25 mm x 20 mm 2.25 mm x 25 mm 2.25 mm x 30 mm 2.25 mm x 35mm 2.25 mm x 40 mm 2.50 mm x 10 mm 2.50 mm x 15 mm 2.50 mm x 20 mm 2.50 mm x25 mm 2.50 mm x 30 mm 2.50 mm x 35 mm 2.50 mm x 40 mm 2.75 mm x 10 mm 2.75 mm x 15 mm 2.75 mm x 20 mm 2.75 mm x2 5mm 2.75 mm x 30 mm 2.75 mm x 35 mm 2.75 mm x 40 mm 3.00 mm x 10 mm 3.00 mm x 15 mm 3.00 mm x 20 mm 3.00 mm x 25 mm 3.00 mm x 30 mm 3.00 mm x 35 mm 3.00 mm x 40 mm 3.50 mm x 10 mm 3.50 mm x 15 mm 3.50 mm x20 mm 3.50 mm x 25 mm 3.50 mm x 30 mm 3.50 mm x 35 mm 3.50 mm x 40 mm 4.00 mm x 10 mm 4.00 mm x 15 mm 4.00 mm x 20 mm 4.00 mm x 25 mm 4.00 mm x 30 mm 4.00 mm x 35 mm 4.00 mm x 40 mm
Model Identifier(s)
CMT15010 CMT15015 CMT15020 CMT15025 CMT15030 CMT15035 CMT15040 CMT20010 CMT20015 CMT20020 CMT20025 CMT20030 CMT20035 CMT20040 CMT22510 CMT22515 CMT22520 CMT22525 CMT22530 CMT22535 CMT22540 CMT25010 CMT25015 CMT25020 CMT25025 CMT25030 CMT25035 CMT25040 CMT27510 CMT27515 CMT27520 CMT27525 CMT27530 CMT27535 CMT27540 CMT30010 CMT30015 CMT30020 CMT30025 CMT30030 CMT30035 CMT30040 CMT35010 CMT35015 CMT35020 CMT35025 CMT35030 CMT35035 CMT35040 CMT40010 CMT40015 CMT40020 CMT40025 CMT40030 CMT40035 CMT40040