Glucose IVD, reagent - UK MHRA Medical Device Registration

Glucose IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 94017. The device is manufactured by Hygieia, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Advena 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 IVD, reagent

MHRA Device ID: 94017•Ref: 94017

Device Type

In Vitro Diagnostic Device

Devices

Glucose IVD, reagent

Type

IVD Annex II List B

Date Registered

Nov 26, 2024

Last Updated

Aug 9, 2024

Manufacturer Information

Name

Hygieia, Inc.

Address

17187 N Laurel Park Drive, Suite 225

Livonia, Michigan, United States

Created Date

Aug 12, 2021

Authorized Representative

Name

Advena Ltd

Relationship Type

UK Responsible Person

Address

Pure Offices Plato Close

Warwick, England, United Kingdom

Postcode: CV34 6WE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Hygieia, Inc. (2)

Glucose monitoring system IVD, home-use

Type: In Vitro Diagnostic Device

Registered: Dec 29, 2021

Home pharmaceutical management support software

Type: General Medical Device

Registered: Dec 29, 2021

Other Products from Same Authorized Representative (10)

Glucose IVD, reagent - 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 monitoring system IVD, home-use

Home pharmaceutical management support software

Medicine cup, single-use

Tourniquet cuff, single-use

Surgical instrument linear advancement system

Attendant-only-propelled wheelchair, non-bariatric

Push-rim manual wheelchair, non-bariatric

Examination/treatment table paper holder

Headphone cover

Medical equipment/instrument drape, reusable

ENFit oral/enteral syringe, single-use

Basic electric hospital bed