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Annalise-AI Annalise Enterprise - HSA Registration DE0508329

Access comprehensive regulatory information for Annalise-AI Annalise Enterprise in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508329 and owned by Annalise-AI Pty Ltd. The device was registered on July 26, 2023.

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 C
DE0508329
Annalise-AI Annalise Enterprise
HSA Registration Number: DE0508329
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Product Description

Annalise Enterprise is a medical device intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings. Annalise Enterprise identifies suspected findings in: โ€ข non-contrast brain CT scans (brain kernel) of adult patients For CT Brain (CTB), the device improves the detection of radiological findings visible on non-contrast CT brain scans.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508329
Registration Date
July 26, 2023
Change Notification Approval Date
July 11, 2024
Retention Due Date
July 25, 2025
Product Owner
Short Name
Annalise-AI Pty Ltd
Address
Level P, 24 Campbell St, Sydney, NSW 2000, AUSTRALIA
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #02-08, SINGAPORE 159557
Model Information
Model Name(s)
Annalise Enterprise
Model Identifier(s)
Annalise Enterprise