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JOTEC E-xpand Stent Graft Balloon Catheter - HSA Registration DE0504685

Access comprehensive regulatory information for JOTEC E-xpand Stent Graft Balloon 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 DE0504685 and owned by JOTEC GmbH. The device was registered on July 13, 2020.

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
DE0504685
JOTEC E-xpand Stent Graft Balloon Catheter
HSA Registration Number: DE0504685
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Product Description

The E-xpand Stent Graft Balloon Catheter has been developed for use with JOTEC’s self-expanding endovascular Stent Graft Systems and is designed to facilitate Stent Graft expansion.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0504685
Registration Date
July 13, 2020
Retention Due Date
July 12, 2025
Product Owner
Short Name
JOTEC GmbH
Address
Lotzenacker 23, 72379 Hechingen, GERMANY
Registrant
Address
1 MARINA BOULEVARD, ONE MARINA BOULEVARD, #28-00, SINGAPORE 018989
Importer
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Model Information
Model Name(s)
E-xpand Stent Graft Balloon Catheter
Model Identifier(s)
85XX0050N35-00