Singapore HSA registration DE0507627
Philips Sentinelle Vanguard Breast MRI Table and Tabletop Coil
Singapore·CLASS B·Philips Medical Systems Nederland B.V.·Registered December 22, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0507627
- Registration Date
- December 22, 2022
- Retention Due Date
- December 21, 2025
Product description
The Breast MRI Table and Tabletop are designed to provide magnetic resonance (MR) images of breast anatomy when used in conjunction with a GE MR scanner. The images can be interpreted by a trained physician. When used with a single-use biopsy grid, the Sentinelle Breast MRI Table and Tabletop for GE permit access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
Product Owner
- Short Name
- Philips Medical Systems Nederland B.V.
- Address
- Veenpluis 6, 5684 PC Best, NETHERLANDS
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- Vanguard Breast MRI Tabletop Coil Vanguard Breast MRI Table Vanguard Breast MRI Tabletop Coil
- Model Identifier(s)
- M3340CW M7000FG M7000FJ
About this record
Access comprehensive regulatory information for Philips Sentinelle Vanguard Breast MRI Table and Tabletop Coil in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507627 and owned by Philips Medical Systems Nederland B.V.. The device was registered on December 22, 2022.
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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