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Olea Medical Breastscape - HSA Registration DE0504899

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.

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CLASS B
DE0504899
Olea Medical Breastscape
HSA Registration Number: DE0504899
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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.

Device 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 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