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Radiobotics RBfracture - HSA Registration DE0509747

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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CLASS B
DE0509747
Radiobotics RBfracture
HSA Registration Number: DE0509747
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Product Description

RBfracture is a computer-assisted detection and diagnosis software device to assist healthcare professionals in reviewing trauma skeletal radiographs. The expected clinical bene๏ฌt of RBfracture is to reduce the number of missed fractures impacting the health of individuals.

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 Owner
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