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 129009. The device is manufactured by Hygieia, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is QNET 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: 129009•Ref: 129009

Device Type

In Vitro Diagnostic Device

Devices

Glucose monitoring system IVD, home-use

Type

IVD Devices for Self-Testing

Date Registered

Dec 29, 2021

Last Updated

Oct 13, 2022

Manufacturer Information

Name

Hygieia, Inc.

Address

28803 8 Mile Rd.

Livonia, United States

Created Date

Dec 29, 2021

Authorized Representative

Name

QNET Ltd

Relationship Type

UK Responsible Person

Address

Livingstone House 309 Harrow Road

Wembley, Middlesex, England, United Kingdom

Postcode: HA9 6BD

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Hygieia, Inc. (2)

Glucose IVD, reagent

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Home pharmaceutical management support software

Type: General Medical Device

Registered: Dec 29, 2021

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

Glucose IVD, reagent

Home pharmaceutical management support software

Leg/knee cushion

Operating table patient positioning set, reusable

Airway pressure monitor, non-powered

CPAP/BPAP face mask, single-use

Cricothyrotomy kit, single-use

Exhaled-gas oesophageal intubation detector, adult

Heat/moisture exchanger/microbial medical gas filter

In-line CPAP set, non-nebulizing

Ventilator breathing circuit, single-use

Cervical spine collar, single-use