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BIOTRONIK PK PAPYRUS COVERED CORONARY STENT SYSTEM - HSA Registration DE0501002

Access comprehensive regulatory information for BIOTRONIK PK PAPYRUS COVERED CORONARY STENT SYSTEM in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0501002 and owned by Biotronik AG. The device was registered on December 26, 2017.

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
DE0501002
BIOTRONIK PK PAPYRUS COVERED CORONARY STENT SYSTEM
HSA Registration Number: DE0501002
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Product Description

PK Papyrus is indicated for treatment of acute coronary artery perforations.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0501002
Registration Date
December 26, 2017
Change Notification Approval Date
May 15, 2025
Retention Due Date
December 25, 2025
Product Owner
Short Name
Biotronik
Address
Ackerstrasse 6, 8180 Bülach, SWITZERLAND
Registrant
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Importer
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Model Information
Model Name(s)
PK Papyrus Covered Coronary Stent System 2.5/15 PK Papyrus Covered Coronary Stent System 3/15 PK Papyrus Covered Coronary Stent System 3.5/15 PK Papyrus Covered Coronary Stent System 4.0/15 PK Papyrus Covered Coronary Stent System 4.5/15 PK Papyrus Covered Coronary Stent System 5/15 PK Papyrus Covered Coronary Stent System 2.5/20 PK Papyrus Covered Coronary Stent System 3.0/20 PK Papyrus Covered Coronary Stent System 3.5/20 PK Papyrus Covered Coronary Stent System 4.0/20 PK Papyrus Covered Coronary Stent System 4.5/20 PK Papyrus Covered Coronary Stent System 5/20 PK Papyrus Covered Coronary Stent System 4.5/26 PK Papyrus Covered Coronary Stent System 5/26 PK Papyrus Covered Coronary Stent System 3/26 PK Papyrus Covered Coronary Stent System 3.5/26 PK Papyrus Covered Coronary Stent System 4/26
Model Identifier(s)
369380 369381 369382 369383 369384 369385 369386 369387 369388 369389 369390 369391 369392 369393 381789 381790 381791