United Kingdom MHRA device registration 165394

Oral/respiratory tract specimen container IVD, additive/medium

United Kingdom·In Vitro Diagnostic Device·Wuhan MGI Tech Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 165394
MHRA Reference Number: 165394
Date Registered: Nov 26, 2024
Last Updated: Jan 24, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Oral/respiratory tract specimen container IVD, additive/medium
Type: Class A

Manufacturer

Name: Wuhan MGI Tech Co., Ltd.
Address: Building 24, Stage 3.1, BioLake Accelerator, No.388, 2nd Gaoxin Road, East Lake High-Tech Development Zone, 430075, Wuhan, P.R.China
Wuhan, China
Created Date: Dec 30, 2022

Authorized Representative

Name: PureUKCA Ltd
Relationship Type: UK Responsible Person
Address: 59 St. Martin's Lane
London, Middlesex, England, United Kingdom
Postcode: WC2N 4JS

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 Wuhan MGI Tech Co., Ltd.

Additional devices registered by the same manufacturer

Laboratory container/microscope slide robotic transfer system IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 166980

Magnetic particle separation instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 165520

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 165516

Nucleic acid sample preparation instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 180432

Nucleic acid sequencing reagent kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 165393

Magnetic particle separation instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 165519

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 165518

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 163882

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 165517

Nucleic acid sample preparation instrument IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 165437

Other products from same authorized representative

Additional devices represented by PureUKCA Ltd in the UK

Monkeypox virus antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Koch Biotechnology (Beijing) Co., Ltd

Device ID: 155411

Cotton wool ball, sterileNov 26, 2024

Type: General Medical Device

Manufacturer: HANGZHOU AOSI HEALTHCARE CO.,LTD.

Device ID: 84801

Glycated haemoglobin (HbA1c) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.

Device ID: 175375

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.

Device ID: 175380

First aid kit, non-medicated, single-useNov 26, 2024

Type: System or Procedure Pack

Manufacturer: HANGZHOU AOSI HEALTHCARE CO.,LTD.

Device ID: 84147

Methylated DNA IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beijing OriginPoly Bio-Tec Co., Ltd.

Device ID: 155599

Buffered sample diluent IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.

Device ID: 175379

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Lvshiyuan Biotechnology Co.,Ltd.

Device ID: 103436

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.

Device ID: 175373

Eye padNov 26, 2024

Type: General Medical Device

Manufacturer: HANGZHOU AOSI HEALTHCARE CO.,LTD.

Device ID: 84800

About this record

Oral/respiratory tract specimen container IVD, additive/medium is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 165394. The device is manufactured by Wuhan MGI Tech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is PureUKCA 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