Singapore HSA registration DE0507715

cNovate Medical Helix Balloon Dilatation Catheter

Singapore·CLASS D·cNovate Medical B.V.·Registered January 27, 2023

Device classification

Device Class: CLASS D
Medical Speciality Area: Cardiovascular

Registration information

Registration Number: DE0507715
Registration Date: January 27, 2023
Change Notification Approval Date: March 25, 2025
Retention Due Date: January 26, 2026

Product description

The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Product Owner

Name: cNovate Medical B.V.
Short Name: cNovate Medical B.V.
Address: Terminalweg 15,, 3821AJ Amersfoort,, NETHERLANDS

Registrant

Name: Alcare Pharmaceuticals Pte Ltd
Address: 12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516

Importer

Name: CURATECH ASIA PTE. LTD.
Address: 22 SIN MING LANE, MIDVIEW CITY, #06-76, SINGAPORE 573969

Model information

Model Name(s): Helix PTCA Balloon Dilatation Catheter Ø1.0 x 5mm Helix PTCA Balloon Dilatation Catheter Ø1.0 x 8mm Helix PTCA Balloon Dilatation Catheter Ø1.0 x 10mm Helix PTCA Balloon Dilatation Catheter Ø1.0 x 12mm Helix PTCA Balloon Dilatation Catheter Ø1.0 x 15mm Helix PTCA Balloon Dilatation Catheter Ø1.0 x 20mm Helix PTCA Balloon Dilatation Catheter Ø1.0 x 25mm Helix PTCA Balloon Dilatation Catheter Ø1.0 x 30mm Helix PTCA Balloon Dilatation Catheter Ø1.25 x 5mm Helix PTCA Balloon Dilatation Catheter Ø1.25 x 8mm Helix PTCA Balloon Dilatation Catheter Ø1.25 x 10mm Helix PTCA Balloon Dilatation Catheter Ø1.25 x 12mm Helix PTCA Balloon Dilatation Catheter Ø1.25 x 15mm Helix PTCA Balloon Dilatation Catheter Ø1.25 x 20mm Helix PTCA Balloon Dilatation Catheter Ø1.25 x 25mm Helix PTCA Balloon Dilatation Catheter Ø1.25 x 30mm Helix PTCA Balloon Dilatation Catheter Ø1.5 x 5mm Helix PTCA Balloon Dilatation Catheter Ø1.5 x 8mm Helix PTCA Balloon Dilatation Catheter Ø1.5 x 10mm Helix PTCA Balloon Dilatation Catheter Ø1.5 x 12mm Helix PTCA Balloon Dilatation Catheter Ø1.5 x 15mm Helix PTCA Balloon Dilatation Catheter Ø1.5 x 20mm Helix PTCA Balloon Dilatation Catheter Ø1.5 x 25mm Helix PTCA Balloon Dilatation Catheter Ø1.5 x 30mm Helix PTCA Balloon Dilatation Catheter Ø1.75 x 5mm Helix PTCA Balloon Dilatation Catheter Ø1.75 x 8mm Helix PTCA Balloon Dilatation Catheter Ø1.75 x 10mm Helix PTCA Balloon Dilatation Catheter Ø1.75 x 12mm Helix PTCA Balloon Dilatation Catheter Ø1.75 x 15mm Helix PTCA Balloon Dilatation Catheter Ø1.75 x 20mm Helix PTCA Balloon Dilatation Catheter Ø1.75 x 25mm Helix PTCA Balloon Dilatation Catheter Ø1.75 x 30mm Helix PTCA Balloon Dilatation Catheter Ø2.0 x 5mm Helix PTCA Balloon Dilatation Catheter Ø2.0 x 8mm Helix PTCA Balloon Dilatation Catheter Ø2.0 x 10mm Helix PTCA Balloon Dilatation Catheter Ø2.0 x 12mm Helix PTCA Balloon Dilatation Catheter Ø2.0 x 15mm Helix PTCA Balloon Dilatation Catheter Ø2.0 x 20mm Helix PTCA Balloon Dilatation Catheter Ø2.0x 25mm Helix PTCA Balloon Dilatation Catheter Ø2.0 x 30mm Helix PTCA Balloon Dilatation Catheter Ø2.25 x 5mm Helix PTCA Balloon Dilatation Catheter Ø2.25 x 8mm Helix PTCA Balloon Dilatation Catheter Ø2.25 x 10mm Helix PTCA Balloon Dilatation Catheter Ø2.25 x 12mm Helix PTCA Balloon Dilatation Catheter Ø2.25 x 15mm Helix PTCA Balloon Dilatation Catheter Ø2.25 x 20mm Helix PTCA Balloon Dilatation Catheter Ø2.25 x 25mm Helix PTCA Balloon Dilatation Catheter Ø2.25 x 30mm Helix PTCA Balloon Dilatation Catheter Ø2.5 x 5mm Helix PTCA Balloon Dilatation Catheter Ø2.5 x 8mm Helix PTCA Balloon Dilatation Catheter Ø2.5 x 10mm Helix PTCA Balloon Dilatation Catheter Ø2.5 x 12mm Helix PTCA Balloon Dilatation Catheter Ø2.5 x 15mm Helix PTCA Balloon Dilatation Catheter Ø2.5 x 20mm Helix PTCA Balloon Dilatation Catheter Ø2.5 x 25mm Helix PTCA Balloon Dilatation Catheter Ø2.5 x 30mm Helix PTCA Balloon Dilatation Catheter Ø2.75 x 5mm Helix PTCA Balloon Dilatation Catheter Ø2.75 x 8mm Helix PTCA Balloon Dilatation Catheter Ø2.75 x 10mm Helix PTCA Balloon Dilatation Catheter Ø2.75 x 12mm Helix PTCA Balloon Dilatation Catheter Ø2.75 x 15mm Helix PTCA Balloon Dilatation Catheter Ø2.75 x 20mm Helix PTCA Balloon Dilatation Catheter Ø2.75 x 25mm Helix PTCA Balloon Dilatation Catheter Ø2.75 x 30mm Helix PTCA Balloon Dilatation Catheter Ø3.0 x 5mm Helix PTCA Balloon Dilatation Catheter Ø3.0 x 8mm Helix PTCA Balloon Dilatation Catheter Ø3.0 x 10mm Helix PTCA Balloon Dilatation Catheter Ø3.0x 12mm Helix PTCA Balloon Dilatation Catheter Ø3.0 x 15mm Helix PTCA Balloon Dilatation Catheter Ø3.0 x 20mm Helix PTCA Balloon Dilatation Catheter Ø3.0 x 25mm Helix PTCA Balloon Dilatation Catheter Ø3.0 x 30mm Helix PTCA Balloon Dilatation Catheter Ø3.25 x 5mm Helix PTCA Balloon Dilatation Catheter Ø3.25 x 8mm Helix PTCA Balloon Dilatation Catheter Ø3.25 x 10mm Helix PTCA Balloon Dilatation Catheter Ø3.25 x 12mm Helix PTCA Balloon Dilatation Catheter Ø3.25 x 15mm Helix PTCA Balloon Dilatation Catheter Ø3.25 x 20mm Helix PTCA Balloon Dilatation Catheter Ø3.25 x 25mm Helix PTCA Balloon Dilatation Catheter Ø3.25 x 30mm Helix PTCA Balloon Dilatation Catheter Ø3.5 x 5mm Helix PTCA Balloon Dilatation Catheter Ø3.5 x 8mm Helix PTCA Balloon Dilatation Catheter Ø3.5 x 10mm Helix PTCA Balloon Dilatation Catheter Ø3.5 x 12mm Helix PTCA Balloon Dilatation Catheter Ø3.5 x 15mm Helix PTCA Balloon Dilatation Catheter Ø3.5 x 20mm Helix PTCA Balloon Dilatation Catheter Ø3.5x 25mm Helix PTCA Balloon Dilatation Catheter Ø3.5 x 30mm Helix PTCA Balloon Dilatation Catheter Ø3.75 x 5mm Helix PTCA Balloon Dilatation Catheter Ø3.75 x 8mm Helix PTCA Balloon Dilatation Catheter Ø3.75 x 10mm Helix PTCA Balloon Dilatation Catheter Ø3.75 x 12mm Helix PTCA Balloon Dilatation Catheter Ø3.75 x 15mm Helix PTCA Balloon Dilatation Catheter Ø3.75 x 20mm Helix PTCA Balloon Dilatation Catheter Ø3.75 x 25mm Helix PTCA Balloon Dilatation Catheter Ø3.75 x 30mm Helix PTCA Balloon Dilatation Catheter Ø4.0 x 5mm Helix PTCA Balloon Dilatation Catheter Ø4.0 x 8mm Helix PTCA Balloon Dilatation Catheter Ø4.0 x 10mm Helix PTCA Balloon Dilatation Catheter Ø4.0 x 12mm Helix PTCA Balloon Dilatation Catheter Ø4.0 x 15mm Helix PTCA Balloon Dilatation Catheter Ø4.0 x 20mm Helix PTCA Balloon Dilatation Catheter Ø4.0 x 25mm Helix PTCA Balloon Dilatation Catheter Ø4.0 x 30mm
Model Identifier(s): CS-1005 CS-1008 CS-1010 CS-1012 CS-1015 CS-1020 CS-1025 CS-1030 CS-1205 CS-1208 CS-1210 CS-1212 CS-1215 CS-1220 CS-1225 CS-1230 CS-1505 CS-1508 CS-1510 CS-1512 CS-1515 CS-1520 CS-1525 CS-1530 CS-1705 CS-1708 CS-1710 CS-1712 CS-1715 CS-1720 CS-1725 CS-1730 CS-2005 CS-2008 CS-2010 CS-2012 CS-2015 CS-2020 CS-2025 CS-2030 CS-2205 CS-2208 CS-2210 CS-2212 CS-2215 CS-2220 CS-2225 CS-2230 CS-2505 CS-2508 CS-2510 CS-2512 CS-2515 CS-2520 CS-2525 CS-2530 CS-2705 CS-2708 CS-2710 CS-2712 CS-2715 CS-2720 CS-2725 CS-2730 CS-3005 CS-3008 CS-3010 CS-3012 CS-3015 CS-3020 CS-3025 CS-3030 CS-3205 CS-3208 CS-3210 CS-3212 CS-3215 CS-3220 CS-3225 CS-3230 CS-3505 CS-3508 CS-3510 CS-3512 CS-3515 CS-3520 CS-3525 CS-3530 CS-3705 CS-3708 CS-3710 CS-3712 CS-3715 CS-3720 CS-3725 CS-3730 CS-4005 CS-4008 CS-4010 CS-4012 CS-4015 CS-4020 CS-4025 CS-4030

About this record

Access comprehensive regulatory information for cNovate Medical Helix Balloon Dilatation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507715 and owned by cNovate Medical B.V.. The device was registered on January 27, 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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