United Kingdom MHRA device registration 146614

Glucose monitoring system IVD, home-use

United Kingdom·In Vitro Diagnostic Device·Acon Laboratories, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 146614
MHRA Reference Number: 146614
Date Registered: Nov 26, 2024
Last Updated: Mar 12, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Glucose monitoring system IVD, home-use
Type: IVD General

Manufacturer

Name: Acon Laboratories, Inc.
Address: 5850 Oberlin Drive, #340
San Diego, CA, United States
Created Date: Mar 31, 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

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

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

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

Other products from Acon Laboratories, Inc.

Additional devices registered by the same manufacturer

Glucose IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 146606

Haemoglobin detection IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 146619

Urine analyser IVD, laboratoryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 179231

Urine analyser IVD, point-of-careNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 179230

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 146594

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 146599

Ketone (acetoacetate) IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 184605

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 146602

Multiple urine analyte IVD, kit, rapid colorimetric, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 146639

Dengue virus antigen/antibody IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 172827

Other products from same authorized representative

Additional devices represented by MDSS-UK RP LIMITED in the UK

Nasogastric tube holder, noninvasiveNov 26, 2024

Type: General Medical Device

Manufacturer: Dale Medical Products

Device ID: 170557

Orthopaedic implant-instrument extension adaptor, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: PB Swiss Tools AG

Device ID: 118280

Electrode conductive mediumNov 26, 2024

Type: General Medical Device

Manufacturer: Parker Laboratories, Inc.

Device ID: 124779

Body-surface ultrasound imaging transducer coverNov 26, 2024

Type: General Medical Device

Manufacturer: Parker Laboratories, Inc.

Device ID: 194514

Surgical binoculars, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: ExamVision ApS

Device ID: 165857

Thyroid blocking immunoglobulin (TBI) IVD, kit, bioassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Diagnostic Hybrids, Inc.

Device ID: 140263

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Diagnostic Hybrids, Inc.

Device ID: 140264

Screw extractor, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: PB Swiss Tools AG

Device ID: 101232

Surgical screwdriver, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: PB Swiss Tools AG

Device ID: 101230

Non-adhesive device retention bandageNov 26, 2024

Type: General Medical Device

Manufacturer: Dale Medical Products

Device ID: 170556

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 146614. The device is manufactured by Acon Laboratories, Inc. from United States, classified as In Vitro Diagnostic 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device