Glucose monitoring system IVD, home-use - UK MHRA Medical Device Registration

Glucose monitoring system IVD, home-use is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 66326. The device is manufactured by Roche Diabetes Care Gmbh from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diabetes Care 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

In Vitro Diagnostic Device

🇬🇧

Glucose monitoring system IVD, home-use

MHRA Device ID: 66326•Ref: 66326

Device Type

In Vitro Diagnostic Device

Devices

Glucose monitoring system IVD, home-use

Type

IVD Annex II List B

Date Registered

Jul 9, 2024

Last Updated

Jul 3, 2024

Manufacturer Information

Name

Roche Diabetes Care Gmbh

Address

Sandhofer Strasse 116

Mannheim, Germany

Created Date

Feb 9, 2021

Authorized Representative

Name

Roche Diabetes Care Ltd.

Relationship Type

UK Responsible Person

Address

Charles Avenue, Burgess Hill, RH15 9RY

Burgess Hill, , United Kingdom

Postcode: RH15 9RY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Roche Diabetes Care Gmbh (10)

Other Products from Same Authorized Representative (10)

Glucose monitoring system IVD, home-use - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Ambulatory insulin infusion pump remote control/blood glucose analyser

Blood lancing device tip

Electric infusion pump administration set, single-use

Insulin infusion cannula introducer

Manual blood lancing device, reusable

Manual blood lancing device, reusable

Self-care monitoring/reporting software

Ambulatory insulin infusion administration set/reservoir kit

Ambulatory insulin infusion pump reservoir

Ambulatory insulin infusion pump remote control/blood glucose analyser

Self-care monitoring/reporting software

Self-care monitoring/reporting software

Ambulatory insulin infusion pump software, patient-dosing

Ambulatory insulin infusion pump remote control/blood glucose analyser

Ambulatory insulin infusion pump remote control/blood glucose analyser

Blood lancing device tip

Electric infusion pump administration set, single-use

Insulin infusion cannula introducer

Manual blood lancing device, reusable

Manual blood lancing device, reusable