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Singapore HSA registration DE0510633

Eximo Auryon Laser System

Singapore flagSingapore·CLASS C·Eximo Medical Ltd·Registered April 25, 2025
Device classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0510633
Registration Date
April 25, 2025
Retention Due Date
April 24, 2026
Product description
The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries. The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra- inguinal stenoses and occlusions.
Product Owner
Name
Eximo Medical Ltd
Short Name
Eximo Medical Ltd
Address
3 Pekeris, Rehovot, 7670203, ISRAEL
Registrant
Name
ANGEION MEDICAL INTERNATIONAL PTE. LTD.
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Importer
Name
ANGEION MEDICAL INTERNATIONAL PTE. LTD.
Address
100 PASIR PANJANG ROAD, 100 PASIR PANJANG, #05-02, SINGAPORE 118518
Model information
Model Name(s)
Auryon Laser System Auryon Atherectomy Catheter 1.5mm OTW Auryon Atherectomy Catheter 1.5mm OTW Hydrophilic Coating Auryon Atherectomy Catheter 0.9mm OTW Auryon Atherectomy Catheter 0.9mm OTW Hydrophilic Coating Auryon Atherectomy Catheter 2.0mm OTW Auryon Atherectomy Catheter 2.0mm OTW Hydrophilic Coating Auryon Atherectomy Catheter 2.35mm OTW Auryon Atherectomy Catheter 2.35mm OTW Hydrophilic Coating
Model Identifier(s)
EXM-2002-1000 EXM-4001-0000 EXM-4001-H000 EXM-4002-0000 EXM-4002-H000 EXM-4003-0000 EXM-4003-H000 EXM-4004-0000 EXM-4004-H000
About this record

Access comprehensive regulatory information for Eximo Auryon Laser System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510633 and owned by Eximo Medical Ltd. The device was registered on April 25, 2025.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C