Singapore HSA registration DE0018159

BIOTRONIK Pantera Pro Coronary Dilatation Catheter

Singapore·CLASS D·Biotronik AG·Registered May 26, 2016

Device classification

Device Class: CLASS D
Medical Speciality Area: Cardiovascular

Registration information

Registration Number: DE0018159
Registration Date: May 26, 2016
Change Notification Approval Date: May 15, 2025
Retention Due Date: May 25, 2025

Product description

Is intended to be used for dilatation of stenotic segments in coronary arteries or bypass grafts. The dilatation balloon is designed to inflate to a known diameter and length at recommended inflation pressures.

Product Owner

Name: Biotronik AG
Short Name: Biotronik
Address: Ackerstrasse 6, 8180 Bülach, SWITZERLAND

Registrant

Name: BIOTRONIK ASIA PACIFIC PTE. LTD.
Address: 165 KALLANG WAY, #07-00, SINGAPORE 349257

Importer

Name: BIOTRONIK ASIA PACIFIC PTE. LTD.
Address: 165 KALLANG WAY, #07-00, SINGAPORE 349257

Model information

Model Name(s): Pantera Pro Coronary Dilatation Catheter 1.25/6 Pantera Pro Coronary Dilatation Catheter 1.5/6 Pantera Pro Coronary Dilatation Catheter1.25/10 Pantera Pro Coronary Dilatation Catheter1.5/10 Pantera Pro Coronary Dilatation Catheter2.0/10 Pantera Pro Coronary Dilatation Catheter2.5/10 Pantera Pro Coronary Dilatation Catheter3.0/10 Pantera Pro Coronary Dilatation Catheter 3.5/10 Pantera Pro Coronary Dilatation Catheter 4.0/10 Pantera Pro Coronary Dilatation Catheter 1.25/15 Pantera Pro Coronary Dilatation Catheter 1.5/15 Pantera Pro Coronary Dilatation Catheter 2.0/15 Pantera Pro Coronary Dilatation Catheter 2.5/15 Pantera Pro Coronary Dilatation Catheter 3.0/15 Pantera Pro Coronary Dilatation Catheter 3.5/15 Pantera Pro Coronary Dilatation Catheter 4.0/15 Pantera Pro Coronary Dilatation Catheter 1.25/20 Pantera Pro Coronary Dilatation Catheter 1.5/20 Pantera Pro Coronary Dilatation Catheter 2.0/20 Pantera Pro Coronary Dilatation Catheter 2.5/20 Pantera Pro Coronary Dilatation Catheter 3.0/20 Pantera Pro Coronary Dilatation Catheter 3.5/20 Pantera Pro Coronary Dilatation Catheter 4.0/20 Pantera Pro Coronary Dilatation Catheter 2.0/25 Pantera Pro Coronary Dilatation Catheter 2.5/25 Pantera Pro Coronary Dilatation Catheter 3.0/25 Pantera Pro Coronary Dilatation Catheter 3.5/25 Pantera Pro Coronary Dilatation Catheter 4.0/25 Pantera Pro Coronary Dilatation Catheter2.0/30 Pantera Pro Coronary Dilatation Catheter 2.5/30 Pantera Pro Coronary Dilatation Catheter 3.0/30 Pantera Pro Coronary Dilatation Catheter 3.5/30 Pantera Pro Coronary Dilatation Catheter 4.0/30
Model Identifier(s): 393289 393290 393291 393292 393293 393294 393295 393296 393297 393298 393299 393300 393301 393302 393303 393304 393305 393306 393307 393308 393309 393310 393311 393312 393313 393314 393315 393316 393317 393318 393319 393320 393321

About this record

Access comprehensive regulatory information for BIOTRONIK Pantera Pro Coronary 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 DE0018159 and owned by Biotronik AG. The device was registered on May 26, 2016.

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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