United Kingdom MHRA device registration 148530

Multiple clinical chemistry analyser IVD, home-use

United Kingdom·In Vitro Diagnostic Device·e-LinkCare Meditech Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 148530
MHRA Reference Number: 148530
Date Registered: Nov 26, 2024
Last Updated: Apr 16, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple clinical chemistry analyser IVD, home-use
Type: IVD Devices for Self-Testing

Manufacturer

Name: e-LinkCare Meditech Co., Ltd.
Address: No.9 Tongjiang Road, Baita District, Xianju Economic Development Zone,
Taizhou, Zhejiang, China
Created Date: Aug 28, 2020

Authorized Representative

Name: Wellkang Ltd
Relationship Type: Authorised Representative (Northern Ireland)
Address: Enterprise Hub, NW Business Complex 1 Beraghmore Road
Derry, Northern Ireland, Northern Ireland, United Kingdom
Postcode: BT48 8SE

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 e-LinkCare Meditech Co., Ltd.

Additional devices registered by the same manufacturer

Blood glucose/blood pressure monitoring system, point-of-careNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 148531

Diagnostic spirometer, professionalNov 26, 2024

Type: General Medical Device

Device ID: 138632

General specimen container IVD, additive/mediumNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 57633

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

Type: In Vitro Diagnostic Device

Device ID: 57054

Uric acid IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 140620

Incentive spirometerNov 26, 2024

Type: General Medical Device

Device ID: 182633

Medicine chamber spacer, reusableNov 26, 2024

Type: General Medical Device

Device ID: 182634

Multiple clinical chemistry analyte monitoring system IVD, point-of-careNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 144702

Spirometry/pulmonary function pressure tubeNov 26, 2024

Type: General Medical Device

Device ID: 138631

Electrochemical breath analyser IVD, point-of-careNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 144703

Other products from same authorized representative

Additional devices represented by Wellkang Ltd in the UK

Disposable surgical irrigation/aspiration systemNov 26, 2024

Type: General Medical Device

Manufacturer: Apex (Guangzhou) Tools & Orthopedics Co.

Device ID: 155233

Wire/ligature passer, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: Apex (Guangzhou) Tools & Orthopedics Co.

Device ID: 155235

Multiple vital physiological parameter monitoring system, clinicalNov 26, 2024

Type: General Medical Device

Manufacturer: APK Technology Co., Ltd.

Device ID: 88847

Ankle/foot orthosisNov 26, 2024

Type: General Medical Device

Manufacturer: POD Active Pty Ltd

Device ID: 80737

Faecal incontinence collector, skin-fixationNov 26, 2024

Type: General Medical Device

Manufacturer: Changzhou DSB Medical Co.,Ltd.

Device ID: 199947

Buffered sample diluent IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: URIT Medical Electronic Co., Ltd.

Device ID: 175313

Reticulocyte count IVD, kit, cell countNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: URIT Medical Electronic Co., Ltd.

Device ID: 175316

Urine analyser IVD, laboratoryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: URIT Medical Electronic Co., Ltd.

Device ID: 175505

Surgical/medical face mask, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Hunan Triplex Precision Medical Devices Co., Ltd.

Device ID: 69046

Surgical irrigation system nozzleNov 26, 2024

Type: General Medical Device

Manufacturer: Apex (Guangzhou) Tools & Orthopedics Co.

Device ID: 108045

About this record

Multiple clinical chemistry analyser IVD, home-use is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 148530. The device is manufactured by e-LinkCare Meditech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang 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