Singapore HSA registration DE0508324
Qualimed GSQ Guiding Sheath
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 description
The Guiding Sheath (GSQ) is intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary, central circulatory system and neuro vasculature.
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
About this record
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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