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Singapore HSA registration DE0510319

Heuron Heuron IPD

Singapore flagSingapore·CLASS B·Heuron·Registered February 07, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0510319
Registration Date
February 07, 2025
Retention Due Date
February 06, 2026
Product description
This device is a diagnostic aid software to assist medical professionals in diagnosing neurodegenerative Parkinson’s disease by analyzing nigrosome 1 MR images and clinical information of neurodegenerative Parkinson’s disease patients and normal people taken through nigrosome 1 imaging protocol.
Product Owner
Name
Heuron
Short Name
Heuron
Address
Heuron Co., Ltd, 10F, C, 150 Yeongdeungpo-ro,, Yeongdeungpo-gu, Seoul, 07292, Republic of Korea, Seoul, KOREA, REPUBLIC OF
Registrant
Name
ACCESS-2-HEALTHCARE
Address
42 KIM YAM ROAD, OLEANAS RESIDENCE, #19-02, SINGAPORE 239347
Importer
Name
Access-2-Healthcare (Singapore) Pte Ltd
Address
160 ROBINSON ROAD, SINGAPORE BUSINESS FEDERATION CENTER, #14-04, SINGAPORE 068914
Model information
Model Name(s)
Heuron IPD Heuron IPD
Model Identifier(s)
H-PD-D01 H-PD-D02
About this record

Access comprehensive regulatory information for Heuron Heuron IPD in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510319 and owned by Heuron. The device was registered on February 07, 2025.

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