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Olea Medical Olea Sphere - HSA Registration DE0505227

Access comprehensive regulatory information for Olea Medical Olea Sphere in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505227 and owned by OLEA MEDICAL S.A.S.. The device was registered on December 09, 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
DE0505227
Olea Medical Olea Sphere
HSA Registration Number: DE0505227
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Product Description

Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT).โ€

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0505227
Registration Date
December 09, 2020
Retention Due Date
December 08, 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)
OLEA SPHERE
Model Identifier(s)
OLEA SPHERE