United Kingdom MHRA device registration 191770

Self-care monitoring/reporting software

United Kingdom·General Medical Device·i-SENS, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 191770
MHRA Reference Number: 191770
Date Registered: Nov 26, 2024
Last Updated: May 9, 2024

Device classification

Device Type: General Medical Device
Devices: Self-care monitoring/reporting software
Type: Class I

Manufacturer

Name: i-SENS, Inc.
Address: 43, Banpo-daero 28-gil, Seocho-gu
Seoul , South Korea
Created Date: Jul 21, 2021

Authorized Representative

Name: MT Promedt Consulting Ltd
Relationship Type: UK Responsible Person
Address: Beaver House, 23-38 Hythe Bridge Street
Oxford, England, United Kingdom
Postcode: OX1 2EP

Similar products

Devices with a matching generic name or device type registered with MHRA

Multidisciplinary medical image management softwareN/A

Type: General Medical Device

Manufacturer: oneFIT medical

Device ID: 131185

Bone distraction forcepsN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 127363

Internal orthopaedic fixation system, cerclage wire/cable, sterileN/A

Type: General Medical Device

Manufacturer: Arthrex Inc.

Device ID: 176386

Hypnotherapy virtual reality softwareN/A

Type: General Medical Device

Manufacturer: Oncomfort SA

Device ID: 137753

Patient transfer assistive bed/mobile chairN/A

Type: General Medical Device

Manufacturer: Orthos European Inclusive Solutions

Device ID: 162072

Arthrodesis nailN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 78961

Nasal irrigation saline solutionN/A

Type: General Medical Device

Manufacturer: East Midlands Pharma Ltd (EMP Ltd)

Device ID: 176112

Decontamination floor mat, single-useN/A

Type: General Medical Device

Manufacturer: Arthrex Inc.

Device ID: 176391

Urodynamic manometric catheter, non-electronicN/A

Type: General Medical Device

Manufacturer: Malvern Medical Developments Limited

Device ID: 176965

Compression/pressure sock/stocking, single-useN/A

Type: General Medical Device

Manufacturer: Varimed Medikal Sanayi ve Ticaret Limited Sireketi

Device ID: 176079

Other products from i-SENS, Inc.

Additional devices registered by the same manufacturer

Albumin/creatinine ratio (ACR) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 111557

Glucose monitoring system IVD, home-useNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 89796

Glycated haemoglobin (HbA1c) IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 111556

Ketone (acetoacetate) IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 198053

Ketone (acetoacetate) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 198052

Percutaneous interstitial-fluid glucose monitoring system, electrochemicalNov 26, 2024

Type: General Medical Device

Device ID: 191771

Albumin/creatinine ratio (ACR) IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 111558

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-careNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 200134

Glycated haemoglobin (HbA1c) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 111555

Metabolic profile clinical chemistry analyser IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 200133

Other products from same authorized representative

Additional devices represented by MT Promedt Consulting Ltd in the UK

Laparoscopic motorized instrument control unit

Type: General Medical Device

Manufacturer: American Orthodontics Corp

Device ID: 175758

Monospecific anti-complement component C3d (anti-C3d) IVD, antibodyNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Dominion Biologicals Limited

Device ID: 77083

Anti-S [MNS004] red blood cell grouping IVD, antibodyNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor, Inc.

Device ID: 138439

Anti-Fy^b red blood cell grouping IVD, antibodyNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor, Inc.

Device ID: 138414

Anti-k (KEL002) red blood cell grouping IVD, antibodyNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor, Inc.

Device ID: 138428

Anti-S [MNS003] red blood cell grouping IVD, antibodyNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor, Inc.

Device ID: 138440

Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibodyNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Dominion Biologicals Limited

Device ID: 77081

Bovine serum albumin (BSA) immunohaematology reagent IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor, Inc.

Device ID: 138415

Buffered isotonic saline reagent IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Immucor, Inc.

Device ID: 138447

Anti-E [RH005] red blood cell grouping IVD, antibodyNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Dominion Biologicals Limited

Device ID: 77080

About this record

Self-care monitoring/reporting software is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 191770. The device is manufactured by i-SENS, Inc. from South Korea, classified as General Medical Device. The authorized representative in the UK is MT Promedt Consulting 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 DatabasePowered by Pure Global AIMHRA RegisteredGeneral Medical Device