Singapore HSA registration DE0508679
Endomagnetics Magtrace Magnetic Tracer and Sentimag System
Singapore·CLASS B·Endomagnetics Ltd·Registered November 21, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0508679
- Registration Date
- November 21, 2023
- Retention Due Date
- November 20, 2025
Product description
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. It is specifically designed to detect the Magtrace superparamagnetic tracer used to locate sentinel nodes in Sentinel Lymph Node Biopsy (SLNB) or with Magseed which is a ferromagnetic soft tissue marker. Neither Magseed nor Magtrace have inherent magnetic properties. They can only be detected by the paramagnetic induction by Sentimag which also detects their presence.
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)
- Magtrace Magtrace 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)
- MTVC10 MTVC2 SMA SMB02 SMC02 SMH02 SMP02 SMS02 SPC02-XX
About this record
Access comprehensive regulatory information for Endomagnetics Magtrace Magnetic Tracer and Sentimag System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508679 and owned by Endomagnetics Ltd. The device was registered on November 21, 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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