United Kingdom MHRA device registration 129009

Glucose monitoring system IVD, home-use

United Kingdom·In Vitro Diagnostic Device·Hygieia, Inc.·Registered Dec 29, 2021

Registration details

Device ID: 129009
MHRA Reference Number: 129009
Date Registered: Dec 29, 2021
Last Updated: Oct 13, 2022

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Glucose monitoring system IVD, home-use
Type: IVD Devices for Self-Testing

Manufacturer

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

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About this record

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.

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