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 205091. The device is manufactured by Tandem Diabetes Care, Inc. from United States, classified as General Medical Device. The authorized representative in the UK is MDSS-UK RP LIMITED.

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: 205091•Ref: 205091

Device Type

General Medical Device

Devices

Self-care monitoring/reporting software

Type

Class I

Date Registered

Nov 26, 2024

Last Updated

Aug 8, 2024

Manufacturer Information

Name

Tandem Diabetes Care, Inc.

Address

12400 High Bluff Drive

San Diego, CA, United States

Created Date

Aug 26, 2021

Authorized Representative

Name

MDSS-UK RP LIMITED

Relationship Type

UK Responsible Person

Address

6 Wilmslow Road, Rusholme

Manchester, England, United Kingdom

Postcode: M14 5TP

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Tandem Diabetes Care, Inc. (9)

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

Manual blood lancing device, single-use

Stationary gamma camera system

Physiologic monitoring system alarm

Bedside information system application software

Wireless patient monitor/sensor reporting software, professional-only

Wireless patient monitor/sensor reporting software, professional-only

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

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

Orthopaedic implant aiming/guiding block, reusable

Bone nail guidewire, reusable

Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Ambulatory insulin infusion pump reservoir

Self-care monitoring/reporting software

Ambulatory insulin infusion pump software, data-display

Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Ambulatory insulin infusion pump software, data-display

Ambulatory insulin infusion pump reservoir

Knee support orthosis

Orthotic insole, prefabricated, non-antimicrobial

Freestanding patient positioner, reusable

Nasal cavity stent, removable, prefabricated

Creatinine IVD, control

Glycated haemoglobin (HbA1c) IVD, calibrator

Glycated haemoglobin (HbA1c) IVD, control

Homocysteine IVD, calibrator

Kappa/lambda light chain immunoglobulin IVD, control

Custom-made lower-limb orthosis