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Qualimed Peripheral Balloon Expandable Stent System (QBX) - HSA Registration DE0510130

Access comprehensive regulatory information for Qualimed Peripheral Balloon Expandable Stent System (QBX) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510130 and owned by QualiMed Innovative Medizinprodukte GmbH. The device was registered on December 11, 2024.

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
DE0510130
Qualimed Peripheral Balloon Expandable Stent System (QBX)
HSA Registration Number: DE0510130
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Product Description

The Peripheral Balloon Expandable Stent System is indicated for use in native peripheral arteries with a diameter between 5.0 and 10.0 mm. The Peripheral Balloon Expandable Stent is to be used to improve the vessel lumen diameter in the treatment of lesions (de novo and restenoses) in external iliac, internal iliac, common iliac, and renal arteries. The SDS is intended to be used as an adjunct to PTA for stenting native peripheral arteries and is designed to perform as a system.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0510130
Registration Date
December 11, 2024
Retention Due Date
December 10, 2025
Product Owner
Short Name
QualiMed Innovative Medizinprodukte GmbH
Address
Boschstraße 16, 21423 Winsen, GERMANY
Registrant
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Importer
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Model Information
Model Name(s)
Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX) Peripheral Balloon Expandable Stent System (QBX)
Model Identifier(s)
08 QBX 050175F 08 QBX 050265F 08 QBX 050365F 08 QBX 050575F 08 QBX 060175F 08 QBX 060265F 08 QBX 060365F 08 QBX 060575F 08 QBX 070175F 08 QBX 070265F 08 QBX 070365F 08 QBX 070575F 08 QBX 080175F 08 QBX 080265F 08 QBX 080365F 08 QBX 080575F 08 QBX 090175F 08 QBX 090265F 08 QBX 090365F 08 QBX 090575F 08 QBX 100175F 08 QBX 100265F 08 QBX 100365F 08 QBX 100575F 13 QBX 050175F 13 QBX 050265F 13 QBX 050365F 13 QBX 050575F 13 QBX 060175F 13 QBX 060265F 13 QBX 060365F 13 QBX 060575F 13 QBX 070175F 13 QBX 070265F 13 QBX 070365F 13 QBX 070575F 13 QBX 080175F 13 QBX 080265F 13 QBX 080365F 13 QBX 080575F 13 QBX 090175F 13 QBX 090265F 13 QBX 090365F 13 QBX 090575F 13 QBX 100175F 13 QBX 100265F 13 QBX 100365F 13 QBX 100575F 15 QBX 050175F 15 QBX 050265F 15 QBX 050365F 15 QBX 050575F 15 QBX 060175F 15 QBX 060265F 15 QBX 060365F 15 QBX 060575F 15 QBX 070175F 15 QBX 070265F 15 QBX 070365F 15 QBX 070575F 15 QBX 080175F 15 QBX 080265F 15 QBX 080365F 15 QBX 080575F 15 QBX 090175F 15 QBX 090265F 15 QBX 090365F 15 QBX 090575F 15 QBX 100175F 15 QBX 100265F 15 QBX 100365F 15 QBX 100575F