United Kingdom MHRA device registration 181308

X-ray image interpretive software

United Kingdom·General Medical Device·Lunit Inc.·Registered Sep 29, 2024

Registration details

Device ID: 181308
MHRA Reference Number: 181308
Date Registered: Sep 29, 2024
Last Updated: Jan 23, 2024

Device classification

Device Type: General Medical Device
Devices: X-ray image interpretive software
Type: Class IIa

Manufacturer

Name: Lunit Inc.
Address: 4-8 F, 374, Gangnam-daero, Gangnam-gu
Seoul, South Korea
Created Date: Nov 6, 2023

Authorized Representative

Name: Obelis UK Ltd
Relationship Type: UK Responsible Person
Address: Sandford Gate, East Point Business Park
Oxford , England, United Kingdom
Postcode: OX4 6LB

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About this record

X-ray image interpretive software is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 181308. The device is manufactured by Lunit Inc. from South Korea, classified as General Medical Device. The authorized representative in the UK is Obelis UK Ltd.

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