Pure Global AI
HSA · registration DE0510055

femtos pEGASUS (HPC) Stent System

SingaporeCardiovascularClass Dfemtos GmbH
Verified
Official record identity
Registration number
DE0510055
Model name
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
PEGASUS-350-15; pEGASUS-350-15-HPC; PEGASUS-350-20; pEGASUS-350-20-HPC; PEGASUS-350-25; pEGASUS-350-25-HPC; PEGASUS-350-30; pEGASUS-350-30-HPC; PEGASUS-450-15; pEGASUS-450-15-HPC; PEGASUS-450-20; pEGASUS-450-20-HPC; PEGASUS-450-25; pEGASUS-450-25-HPC; PEGASUS-450-30; pEGASUS-450-30-HPC
Registration date
November 19, 2024
Source update date
December 04, 2025
Classification
Risk class
Class D
Official value: CLASS D
Published category
Cardiovascular
View exact category matches →
Published parties
Product owner
femtos GmbH
Registrant / registration holder
ANDAMAN MEDICAL PTE. LTD.
Official 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).

Additional source fields
Product owner address
Universitätsstr. 136,, 44799 Bochum, Germany, Germany
Registrant address
300 TAMPINES AVENUE 5, #09-02, INCOME AT TAMPINES JUNCTION, Singapore 529653
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.