United Kingdom MHRA device registration 80323

Glucose/ketone/lipid profile IVD, reagent

United Kingdom·In Vitro Diagnostic Device·SD Biosensor, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 80323
MHRA Reference Number: 80323
Date Registered: Nov 26, 2024
Last Updated: Jun 22, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Glucose/ketone/lipid profile IVD, reagent
Type: IVD Annex II List B

Manufacturer

Name: SD Biosensor, Inc.
Address: C-4th&5th, 16 Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, Republic of Korea
Suwon-si, South Korea
Created Date: May 11, 2021

Authorized Representative

Name: MT Promedt Consulting Ltd
Relationship Type: UK Responsible Person
Address: Beaver House, 23-38 Hythe Bridge Street
Oxford, England, United Kingdom
Postcode: OX1 2EP

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 SD Biosensor, Inc.

Additional devices registered by the same manufacturer

Ferritin IVD, kit, fluorescent immunoassayMar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212395

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)Mar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212390

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, controlMar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212388

Troponin T IVD, controlMar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212392

Troponin I IVD, controlMar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212394

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, rapid colorimetric, clinicalMar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212396

Haemoglobin/glucose-6-phosphate dehydrogenase (G6PD) analyser IVDMar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212389

Troponin I IVD, kit, fluorescent immunoassayMar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212393

Troponin T IVD, kit, fluorescent immunoassayMar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212391

Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinicalFeb 14, 2025

Type: In Vitro Diagnostic Device

Device ID: 210681

Other products from same authorized representative

Additional devices represented by MT Promedt Consulting Ltd in the UK

Laparoscopic motorized instrument control unit

Type: General Medical Device

Manufacturer: American Orthodontics Corp

Device ID: 175758

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

Type: In Vitro Diagnostic Device

Manufacturer: Sugentech, Inc.

Device ID: 86770

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Vela Operations Singapore Pte. Ltd.

Device ID: 148307

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Sugentech, Inc.

Device ID: 111561

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Vela Operations Singapore Pte. Ltd.

Device ID: 148305

Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Vela Operations Singapore Pte. Ltd.

Device ID: 142345

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testingNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Sugentech, Inc.

Device ID: 178929

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Vela Operations Singapore Pte. Ltd.

Device ID: 180563

Nucleic acid sample preparation instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Vela Operations Singapore Pte. Ltd.

Device ID: 180564

Influenza A/B virus antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Sugentech, Inc.

Device ID: 111563

About this record

Glucose/ketone/lipid profile IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 80323. The device is manufactured by SD Biosensor, Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device