X-ray image interpretive software - UK MHRA Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

Powered by Pure Global AI

MHRA Registered

General Medical Device

🇬🇧

X-ray image interpretive software

MHRA Device ID: 181308•Ref: 181308

Device Type

General Medical Device

Devices

X-ray image interpretive software

Type

Class IIa

Date Registered

Sep 29, 2024

Last Updated

Jan 23, 2024

Manufacturer Information

Name

Address

4-8 F, 374, Gangnam-daero, Gangnam-gu

Seoul, South Korea

Created Date

Nov 6, 2023

Authorized Representative

Name

Relationship Type

UK Responsible Person

Address

Sandford Gate, East Point Business Park

Oxford , England, United Kingdom

Postcode: OX4 6LB

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Similar Products (10)

Manual blood lancing device, single-use

Type: General Medical Device

Manufacturer: Tasso, Inc.

Stationary gamma camera system

Type: General Medical Device

Manufacturer: GE Medical Systems Israel Functional Imaging

Physiologic monitoring system alarm

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Bedside information system application software

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Wireless patient monitor/sensor reporting software, professional-only

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Wireless patient monitor/sensor reporting software, professional-only

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Orthopaedic implant aiming/guiding block, reusable

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Bone nail guidewire, reusable

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Other Products from Lunit Inc. (5)

X-ray image interpretive software

Type: General Medical Device

Registered: Nov 26, 2024

X-ray image interpretive software

Type: General Medical Device

Registered: Nov 26, 2024

X-ray image interpretive software

Type: General Medical Device

Registered: Aug 4, 2021

X-ray image interpretive software

Type: General Medical Device

Registered: Aug 4, 2021

X-ray image interpretive software

Type: General Medical Device

Registered: Aug 4, 2021

Other Products from Same Authorized Representative (10)

Total cortisol IVD, reagent

Type: In Vitro Diagnostic Device

Manufacturer: Boditech Med Inc.

Prothrombin time (PT) IVD, reagent

Type: In Vitro Diagnostic Device

Manufacturer: Universal Biosensors Pty Ltd

Air-conduction tinnitus masker, out-of-ear

Type: General Medical Device

Manufacturer: audifon GmbH & Co. KG

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Type: General Medical Device

Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Nylon suture, non-bioabsorbable, monofilament

Type: General Medical Device

Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Nylon suture, non-bioabsorbable, multifilament

Type: General Medical Device

Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Orthopaedic bone screw, non-bioabsorbable, sterile

Type: General Medical Device

Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Orthopaedic bone nut

Type: General Medical Device

Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Orthopaedic bone washer, sterile

Type: General Medical Device

Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Multi-purpose therapeutic saline solution

Type: General Medical Device

Manufacturer: Aurena Laboratories AB