Self-care monitoring/reporting software - UK MHRA Medical Device Registration

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 Database

MHRA Registered

General Medical Device

🇬🇧

Self-care monitoring/reporting software

MHRA Device ID: 191770•Ref: 191770

Device Type

General Medical Device

Devices

Self-care monitoring/reporting software

Type

Class I

Date Registered

Nov 26, 2024

Last Updated

May 9, 2024

Manufacturer Information

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

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from i-SENS, Inc. (10)

Other Products from Same Authorized Representative (10)

Self-care monitoring/reporting software - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Custom-made talus prosthesis

External orthopaedic fixation system, reusable

Bone nail guidewire, reusable

General-body orifice lubricant, non-sterile

External orthopaedic fixation frame calculation software

External orthopaedic fixation system, reusable

Bone nail driver

Bone nail end-cap

Absorbent underpad, non-antimicrobial, single-use

External orthopaedic fixation system, single-use

Albumin/creatinine ratio (ACR) IVD, reagent

Glucose monitoring system IVD, home-use

Glycated haemoglobin (HbA1c) IVD, control

Ketone (acetoacetate) IVD, control

Ketone (acetoacetate) IVD, reagent

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Albumin/creatinine ratio (ACR) IVD, control

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care

Glycated haemoglobin (HbA1c) IVD, reagent

Metabolic profile clinical chemistry analyser IVD

Laparoscopic motorized instrument control unit

Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Clinical laboratory information system application software

Oral/upper respiratory tract specimen collection kit IVD, clinical

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

HLA class I antigen tissue typing IVD, kit, multiplex

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)