United Kingdom MHRA device registration 137101

Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·NeoMedica doo·Registered Apr 11, 2024

Registration details

Device ID: 137101
MHRA Reference Number: 137101
Date Registered: Apr 11, 2024
Last Updated: Oct 17, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: NeoMedica doo
Address: Bulevar Svetog Cara Konstantina 82-86,
Nis, Serbia
Created Date: Nov 26, 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 NeoMedica doo

Additional devices registered by the same manufacturer

Aldosterone IVD, calibratorApr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137229

Aldosterone IVD, controlApr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137230

Aldosterone IVD, kit, enzyme immunoassay (EIA)Apr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137180

Allergen-specific immunoglobulin E (IgE) antibody IVD, controlApr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137198

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)Apr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137085

Alpha-fetoprotein (AFP) IVD, controlApr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137222

Anti-Mullerian hormone (AMH) IVD, controlApr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137227

Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Apr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137282

Borrelia afzelii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Apr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137287

17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)Apr 11, 2024

Type: In Vitro Diagnostic Device

Device ID: 137064

Other products from same authorized representative

Additional devices represented by Wellkang Ltd in the UK

Home BPAP unitNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

Device ID: 182800

Professional high-flow respiratory unit, humidifyingNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

Device ID: 182798

Endodontic paper pointNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen Superline Technology Co. Ltd.

Device ID: 151120

Orthodontic bracket, metalNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen Superline Technology Co. Ltd.

Device ID: 151121

Automatic-inflation electronic sphygmomanometer, portable, arm/wristNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen BSX Technology Electronics Co., Ltd.

Device ID: 133378

Multiple vital physiological parameter monitoring system, clinicalNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.

Device ID: 172902

Noninvasive vascular ultrasound system, line-poweredNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.

Device ID: 172901

Physical therapy transcutaneous neuromuscular electrical stimulation systemNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen Kentro Medical Electronics Co. Ltd.

Device ID: 194411

Physical therapy transcutaneous neuromuscular electrical stimulation systemNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen Kentro Medical Electronics Co. Ltd.

Device ID: 147312

Rectal/vaginal ultrasound imaging transducerNov 26, 2024

Type: General Medical Device

Manufacturer: Shenzhen Sonosray Technology Co., Ltd.

Device ID: 194372

About this record

Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 137101. The device is manufactured by NeoMedica doo from Serbia, 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