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 181307. 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.
Device Type
General Medical Device
Devices
X-ray image interpretive software
Type
Class IIa
Date Registered
Nov 26, 2024
Last Updated
Oct 9, 2024
Name
Lunit Inc.Address
4-8 F, 374, Gangnam-daero, Gangnam-gu
Seoul, South Korea
Created Date
Nov 6, 2023
Name
Obelis UK LtdRelationship Type
Address
Sandford Gate, East Point Business Park
Oxford , England, United Kingdom
Postcode: OX4 6LB
Custom-made talus prosthesis
Type: General Medical Device
Manufacturer: Alloyed Limited
External orthopaedic fixation system, reusable
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Bone nail guidewire, reusable
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
General-body orifice lubricant, non-sterile
Type: General Medical Device
Manufacturer: Turkuaz Saฤlฤฑk Hizmetleri Medikal Temizlik Kimyasal รrรผnler Sanayi ve Ticaret A.ล.
External orthopaedic fixation frame calculation software
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
External orthopaedic fixation system, reusable
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Bone nail driver
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Bone nail end-cap
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Absorbent underpad, non-antimicrobial, single-use
Type: General Medical Device
Manufacturer: Zhejiang B.M. Industrial Co., Ltd.
External orthopaedic fixation system, single-use
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
X-ray image interpretive software
Type: General Medical Device
Registered: Nov 26, 2024
X-ray image interpretive software
Type: General Medical Device
Registered: Sep 29, 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
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
Multiple autoimmune disease-associated antibody screening IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Lansion Biotechnology Co.,Ltd.
SARS-CoV-2 total/neutralizing antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Lansion Biotechnology Co.,Ltd.
Nucleic acid sequencing reagent kit IVD
Type: In Vitro Diagnostic Device
Manufacturer: OncoDNA
Activated partial thromboplastin time (APTT) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Micropoint Biotechnologies Co., Ltd.
Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Micropoint Biotechnologies Co., Ltd.
Anti-Mullerian hormone (AMH) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Micropoint Biotechnologies Co., Ltd.
Coagulation analyser IVD, point-of-care, line-powered
Type: In Vitro Diagnostic Device
Manufacturer: Micropoint Biotechnologies Co., Ltd.
Multiple stroke (cerebral vascular accident) marker IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Lansion Biotechnology Co.,Ltd.

