Singapore HSA registration DE0508329
Annalise-AI Annalise Enterprise
Singapore·CLASS C·Annalise-AI Pty Ltd·Registered July 26, 2023Device 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 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: • 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.
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
About this record
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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