Singapore HSA registration DE0509747
Radiobotics RBfracture
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0509747
- Registration Date
- September 06, 2024
- Retention Due Date
- September 05, 2025
Product description
RBfracture is a computer-assisted detection and diagnosis software device to assist healthcare professionals in reviewing trauma skeletal radiographs. The expected clinical benefit of RBfracture is to reduce the number of missed fractures impacting the health of individuals.
Product Owner
- Name
- Radiobotics ApS
- Short Name
- Radiobotics ApS
- Address
- Esplanaden 8C 1. tv, 1263 Copenhagen, DENMARK
Registrant
- Address
- 111 NORTH BRIDGE ROAD, PENINSULA PLAZA, #21-01, SINGAPORE 179098
Model information
- Model Name(s)
- RBfracture
- Model Identifier(s)
- RBfracture
About this record
Access comprehensive regulatory information for Radiobotics RBfracture in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509747 and owned by Radiobotics ApS. The device was registered on September 06, 2024.
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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