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BIOTRONIK Pantera Pro Coronary Dilatation Catheter - HSA Registration DE0018159

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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CLASS D
DE0018159
BIOTRONIK Pantera Pro Coronary Dilatation Catheter
HSA Registration Number: DE0018159
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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.

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 Owner
Short Name
Biotronik
Address
Ackerstrasse 6, 8180 Bรผlach, SWITZERLAND
Registrant
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Importer
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)
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