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Qualimed GSQ Guiding Sheath - HSA Registration DE0508324

Access comprehensive regulatory information for Qualimed GSQ Guiding Sheath in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508324 and owned by QualiMed Innovative Medizinprodukte GmbH. The device was registered on July 25, 2023.

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 B
DE0508324
Qualimed GSQ Guiding Sheath
HSA Registration Number: DE0508324
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Product Description

The Guiding Sheath (GSQ) is intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary, central circulatory system and neuro vasculature.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508324
Registration Date
July 25, 2023
Change Notification Approval Date
March 05, 2025
Retention Due Date
July 24, 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)
GSQ Guiding Sheath GSQ Guiding Sheath GSQ Guiding Sheath GSQ Guiding Sheath GSQ Guiding Sheath GSQ Guiding Sheath GSQ Guiding Sheath GSQ Guiding Sheath
Model Identifier(s)
GS0180A5 GSQ015A5 GSQ025A5 GSQ045A5 GSQ080A5 GSQ100A5 GSQ120A5 GSQ150A5