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Neurophet Neurophet AQUA - HSA Registration DE0507934

Access comprehensive regulatory information for Neurophet Neurophet AQUA in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507934 and owned by NEUROPHET, Inc.. The device was registered on March 23, 2023.

This page provides complete registration details including product owner information, registrant details, 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
DE0507934
Neurophet Neurophet AQUA
HSA Registration Number: DE0507934
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Product Description

Neurophet AQUA automatically analyze brain images acquired from magnetic resonance imaging (MRI) devices to reconstruct three-dimensional models and quantitatively display the degree of atrophy of the brain by measuring the volume of each cerebral substructure. The software is indicated for use in individuals who are cognitively normal, with or suspected with MCI (mild cognitive impairment), with or suspected with Alzheimerโ€™s disease.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0507934
Registration Date
March 23, 2023
Change Notification Approval Date
July 07, 2023
Retention Due Date
March 22, 2026
Product Owner
Short Name
NEUROPHET, Inc.
Address
12F, 124, Teheran-ro, Gangnam-gu, Seoul, KOREA, REPUBLIC OF
Registrant
Address
300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Model Information
Model Name(s)
Neurophet AQUA
Model Identifier(s)
Neurophet AQUA