cNovate Medical Helix Balloon Dilatation Catheter - HSA Registration DE0507715
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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HSA Official Data
CLASS D
DE0507715
cNovate Medical Helix Balloon Dilatation Catheter
HSA Registration Number: DE0507715
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.
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 Owner
Short Name
cNovate Medical B.V.
Address
Terminalweg 15,, 3821AJ Amersfoort,, NETHERLANDS
Registrant
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Importer
Address
22 SIN MING LANE, MIDVIEW CITY, #06-76, SINGAPORE 573969
Model Information
Model Name(s)
Helix PTCA Balloon Dilatation Catheter ร1.0 x 5mm๏
Helix PTCA Balloon Dilatation Catheter ร1.0 x 8mm
Helix PTCA Balloon Dilatation Catheter ร1.0 x 10mm
Helix PTCA Balloon Dilatation Catheter ร1.0 x 12mm
Helix PTCA Balloon Dilatation Catheter ร1.0 x 15mm
Helix PTCA Balloon Dilatation Catheter ร1.0 x 20mm
Helix PTCA Balloon Dilatation Catheter ร1.0 x 25mm
Helix PTCA Balloon Dilatation Catheter ร1.0 x 30mm
Helix PTCA Balloon Dilatation Catheter ร1.25 x 5mm
Helix PTCA Balloon Dilatation Catheter ร1.25 x 8mm
Helix PTCA Balloon Dilatation Catheter ร1.25 x 10mm
Helix PTCA Balloon Dilatation Catheter ร1.25 x 12mm
Helix PTCA Balloon Dilatation Catheter ร1.25 x 15mm
Helix PTCA Balloon Dilatation Catheter ร1.25 x 20mm
Helix PTCA Balloon Dilatation Catheter ร1.25 x 25mm
Helix PTCA Balloon Dilatation Catheter ร1.25 x 30mm
Helix PTCA Balloon Dilatation Catheter ร1.5 x 5mm
Helix PTCA Balloon Dilatation Catheter ร1.5 x 8mm
Helix PTCA Balloon Dilatation Catheter ร1.5 x 10mm
Helix PTCA Balloon Dilatation Catheter ร1.5 x 12mm
Helix PTCA Balloon Dilatation Catheter ร1.5 x 15mm
Helix PTCA Balloon Dilatation Catheter ร1.5 x 20mm
Helix PTCA Balloon Dilatation Catheter ร1.5 x 25mm
Helix PTCA Balloon Dilatation Catheter ร1.5 x 30mm
Helix PTCA Balloon Dilatation Catheter ร1.75 x 5mm
Helix PTCA Balloon Dilatation Catheter ร1.75 x 8mm
Helix PTCA Balloon Dilatation Catheter ร1.75 x 10mm
Helix PTCA Balloon Dilatation Catheter ร1.75 x 12mm
Helix PTCA Balloon Dilatation Catheter ร1.75 x 15mm
Helix PTCA Balloon Dilatation Catheter ร1.75 x 20mm
Helix PTCA Balloon Dilatation Catheter ร1.75 x 25mm
Helix PTCA Balloon Dilatation Catheter ร1.75 x 30mm
Helix PTCA Balloon Dilatation Catheter ร2.0 x 5mm
Helix PTCA Balloon Dilatation Catheter ร2.0 x 8mm
Helix PTCA Balloon Dilatation Catheter ร2.0 x 10mm
Helix PTCA Balloon Dilatation Catheter ร2.0 x 12mm
Helix PTCA Balloon Dilatation Catheter ร2.0 x 15mm
Helix PTCA Balloon Dilatation Catheter ร2.0 x 20mm
Helix PTCA Balloon Dilatation Catheter ร2.0x 25mm
Helix PTCA Balloon Dilatation Catheter ร2.0 x 30mm
Helix PTCA Balloon Dilatation Catheter ร2.25 x 5mm
Helix PTCA Balloon Dilatation Catheter ร2.25 x 8mm
Helix PTCA Balloon Dilatation Catheter ร2.25 x 10mm
Helix PTCA Balloon Dilatation Catheter ร2.25 x 12mm
Helix PTCA Balloon Dilatation Catheter ร2.25 x 15mm
Helix PTCA Balloon Dilatation Catheter ร2.25 x 20mm
Helix PTCA Balloon Dilatation Catheter ร2.25 x 25mm
Helix PTCA Balloon Dilatation Catheter ร2.25 x 30mm
Helix PTCA Balloon Dilatation Catheter ร2.5 x 5mm
Helix PTCA Balloon Dilatation Catheter ร2.5 x 8mm
Helix PTCA Balloon Dilatation Catheter ร2.5 x 10mm
Helix PTCA Balloon Dilatation Catheter ร2.5 x 12mm
Helix PTCA Balloon Dilatation Catheter ร2.5 x 15mm
Helix PTCA Balloon Dilatation Catheter ร2.5 x 20mm
Helix PTCA Balloon Dilatation Catheter ร2.5 x 25mm
Helix PTCA Balloon Dilatation Catheter ร2.5 x 30mm
Helix PTCA Balloon Dilatation Catheter ร2.75 x 5mm
Helix PTCA Balloon Dilatation Catheter ร2.75 x 8mm๏
Helix PTCA Balloon Dilatation Catheter ร2.75 x 10mm
Helix PTCA Balloon Dilatation Catheter ร2.75 x 12mm
Helix PTCA Balloon Dilatation Catheter ร2.75 x 15mm
Helix PTCA Balloon Dilatation Catheter ร2.75 x 20mm
Helix PTCA Balloon Dilatation Catheter ร2.75 x 25mm
Helix PTCA Balloon Dilatation Catheter ร2.75 x 30mm
Helix PTCA Balloon Dilatation Catheter ร3.0 x 5mm
Helix PTCA Balloon Dilatation Catheter ร3.0 x 8mm
Helix PTCA Balloon Dilatation Catheter ร3.0 x 10mm
Helix PTCA Balloon Dilatation Catheter ร3.0x 12mm
Helix PTCA Balloon Dilatation Catheter ร3.0 x 15mm
Helix PTCA Balloon Dilatation Catheter ร3.0 x 20mm
Helix PTCA Balloon Dilatation Catheter ร3.0 x 25mm
Helix PTCA Balloon Dilatation Catheter ร3.0 x 30mm
Helix PTCA Balloon Dilatation Catheter ร3.25 x 5mm
Helix PTCA Balloon Dilatation Catheter ร3.25 x 8mm
Helix PTCA Balloon Dilatation Catheter ร3.25 x 10mm
Helix PTCA Balloon Dilatation Catheter ร3.25 x 12mm
Helix PTCA Balloon Dilatation Catheter ร3.25 x 15mm
Helix PTCA Balloon Dilatation Catheter ร3.25 x 20mm
Helix PTCA Balloon Dilatation Catheter ร3.25 x 25mm
Helix PTCA Balloon Dilatation Catheter ร3.25 x 30mm
Helix PTCA Balloon Dilatation Catheter ร3.5 x 5mm
Helix PTCA Balloon Dilatation Catheter ร3.5 x 8mm
Helix PTCA Balloon Dilatation Catheter ร3.5 x 10mm
Helix PTCA Balloon Dilatation Catheter ร3.5 x 12mm
Helix PTCA Balloon Dilatation Catheter ร3.5 x 15mm
Helix PTCA Balloon Dilatation Catheter ร3.5 x 20mm
Helix PTCA Balloon Dilatation Catheter ร3.5x 25mm
Helix PTCA Balloon Dilatation Catheter ร3.5 x 30mm
Helix PTCA Balloon Dilatation Catheter ร3.75 x 5mm
Helix PTCA Balloon Dilatation Catheter ร3.75 x 8mm
Helix PTCA Balloon Dilatation Catheter ร3.75 x 10mm
Helix PTCA Balloon Dilatation Catheter ร3.75 x 12mm
Helix PTCA Balloon Dilatation Catheter ร3.75 x 15mm
Helix PTCA Balloon Dilatation Catheter ร3.75 x 20mm
Helix PTCA Balloon Dilatation Catheter ร3.75 x 25mm
Helix PTCA Balloon Dilatation Catheter ร3.75 x 30mm
Helix PTCA Balloon Dilatation Catheter ร4.0 x 5mm
Helix PTCA Balloon Dilatation Catheter ร4.0 x 8mm
Helix PTCA Balloon Dilatation Catheter ร4.0 x 10mm
Helix PTCA Balloon Dilatation Catheter ร4.0 x 12mm
Helix PTCA Balloon Dilatation Catheter ร4.0 x 15mm
Helix PTCA Balloon Dilatation Catheter ร4.0 x 20mm
Helix PTCA Balloon Dilatation Catheter ร4.0 x 25mm๏
Helix PTCA Balloon Dilatation Catheter ร4.0 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