Singapore HSA registration DE0504899
Olea Medical Breastscape
Singapore·CLASS B·OLEA MEDICAL S.A.S.·Registered September 10, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0504899
- Registration Date
- September 10, 2020
- Retention Due Date
- September 09, 2025
Product description
Breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package. It is intended to be used by breast imaging physicians and trained MRI technologists.
Product Owner
- Short Name
- OLEA MEDICAL S.A.S.
- Address
- ZI Athelia IV, 93 Avenue des Sorbiers, 13600 LA CIOTAT, FRANCE
Registrant
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Importer
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Model information
- Model Name(s)
- BREASTSCAPE
- Model Identifier(s)
- Breastscape
About this record
Access comprehensive regulatory information for Olea Medical Breastscape in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504899 and owned by OLEA MEDICAL S.A.S.. The device was registered on September 10, 2020.
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 B