Pure Global

Endomagnetics Magseed Magnetic Marker and Sentimag System - HSA Registration DE0509522

Access comprehensive regulatory information for Endomagnetics Magseed Magnetic Marker and Sentimag 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 DE0509522 and owned by Endomagnetics Ltd. The device was registered on July 12, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0509522
Endomagnetics Magseed Magnetic Marker and Sentimag System
HSA Registration Number: DE0509522
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Endomag Magseed® Magnetic Marker System is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimag® System) the marker is located and surgically removed with the target tissue. The Endomag Sentimag® System is the only non-imaging guidance system intended for use with the Magseed® Magnetic Marker. The Sentimag® is a magnetic material sensor that is designed to induce magnetic properties and detect small amounts of clinically introduced superparamagnetic tracer or ferromagnetic marker.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0509522
Registration Date
July 12, 2024
Retention Due Date
July 11, 2025
Product Owner
Short Name
Endomagnetics Ltd
Address
330 Cambridge Science Park, Milton Road, CB4 0WN, Cambridge, United Kingdom, UNITED KINGDOM
Registrant
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model Information
Model Name(s)
Magseed Magnetic Marker System Magseed Magnetic Marker System Sentimag Footswitch Assembly Sentimag SMB02 Base Unit Assembly Sentimag SMC02 Probe Test Phantom Sentimag SMH02 Probe Holder Sentimag SMP02 Probe Assembly Sentimag System Sentimag Mains lead with ferrite
Model Identifier(s)
SM18-1-07 SM18-1-12 SMA SMB02 SMC02 SMH02 SMP02 SMS02 SPC02-UK