Singapore HSA registration DE0510055
femtos pEGASUS (HPC) Stent System
Singapore·CLASS D·femtos GmbH·Registered November 19, 2024Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0510055
- Registration Date
- November 19, 2024
- Retention Due Date
- November 18, 2025
Product description
The pEGASUS (HPC) Stent System is a self-expanding, tubular vascular implant and allows the endovascular reconstruction of diseased arteries in the cervical and intracranial course. Indications: The self-expanding, tubular vascular implant pEGASUS (HPC) Stent System is used for the endovascular treatment of the following vascular diseases • saccular and fusiform aneurysms in combination with coils, and • atherosclerotic vascular stenosis of intracranial arteries (ICA), middle cerebral artery (MCA), basilar artery (BA), and vertebral artery (VA).
Product Owner
- Name
- femtos GmbH
- Short Name
- femtos GmbH
- Address
- Universitätsstr. 136,, 44799 Bochum, Germany, GERMANY
Registrant
- Address
- 300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Importer
- Address
- 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model information
- Model Name(s)
- pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System pEGASUS Stent System
- Model Identifier(s)
- PEGASUS-350-15 PEGASUS-350-20 PEGASUS-350-25 PEGASUS-350-30 PEGASUS-450-15 PEGASUS-450-20 PEGASUS-450-25 PEGASUS-450-30 pEGASUS-350-15-HPC pEGASUS-350-20-HPC pEGASUS-350-25-HPC pEGASUS-350-30-HPC pEGASUS-450-15-HPC pEGASUS-450-20-HPC pEGASUS-450-25-HPC pEGASUS-450-30-HPC
About this record
Access comprehensive regulatory information for femtos pEGASUS (HPC) 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 DE0510055 and owned by femtos GmbH. The device was registered on November 19, 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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