United Kingdom MHRA device registration 181843

Nucleic acid extraction/isolation kit IVD

United Kingdom·In Vitro Diagnostic Device·Igenesis (Shanghai) Co., Ltd.·Registered Nov 15, 2024

Registration details

Device ID: 181843
MHRA Reference Number: 181843
Date Registered: Nov 15, 2024
Last Updated: Nov 16, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Nucleic acid extraction/isolation kit IVD
Type: IVD General

Manufacturer

Name: Igenesis (Shanghai) Co., Ltd.
Address: Floor 3, Building 1, Lane 500, Furonghua Road, Pudong New Area
Shanghai, China
Created Date: Nov 14, 2023

Authorized Representative

Name: SUNGO Certification Company Limited
Relationship Type: UK Responsible Person
Address: 3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR

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 Igenesis (Shanghai) Co., Ltd.

Additional devices registered by the same manufacturer

Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid techniqueNov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181844

Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid techniqueNov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181847

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181851

Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181855

Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181841

Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)Nov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181850

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181853

Magnetic particle separation instrument IVDNov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181842

Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)Nov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181848

Human papillomavirus (HPV) nucleic acid IVD, probeNov 15, 2024

Type: In Vitro Diagnostic Device

Device ID: 181852

Other products from same authorized representative

Additional devices represented by SUNGO Certification Company Limited in the UK

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

Type: System or Procedure Pack

Manufacturer: Zhejiang Ori-power Medtech Co., Ltd.

Device ID: 153726

Skin treatment/dressing-supportive limb/finger bandage, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Zhejiang Ori-power Medtech Co., Ltd.

Device ID: 145757

Medical device cleaning/disinfection wipeNov 26, 2024

Type: General Medical Device

Manufacturer: Zhejiang Hongyu Medical Commodity Co., Ltd

Device ID: 141958

Scar-management dressing, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: Zhejiang Hongyu Medical Commodity Co., Ltd

Device ID: 102543

Skin-cover sealantNov 26, 2024

Type: General Medical Device

Manufacturer: Zhejiang Hongyu Medical Commodity Co., Ltd

Device ID: 141962

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

Type: General Medical Device

Manufacturer: Zhejiang Hongyu Medical Commodity Co., Ltd

Device ID: 102551

Handgrip disability-assistive walker, non-powered, foldableNov 26, 2024

Type: General Medical Device

Manufacturer: Zhejiang Richall Medical Technology Co., Ltd.

Device ID: 193227

Push-rim manual wheelchair, non-bariatricNov 26, 2024

Type: General Medical Device

Manufacturer: ZHENGZHOU BESCO MEDICAL CO., LTD

Device ID: 181622

Silicone dental impression materialNov 26, 2024

Type: General Medical Device

Manufacturer: Zhengzhou Huaer Electro-Optics Technology Co., Ltd.

Device ID: 159356

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

Type: System or Procedure Pack

Manufacturer: Zhejiang Ori-power Medtech Co., Ltd.

Device ID: 145763

About this record

Nucleic acid extraction/isolation kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 181843. The device is manufactured by Igenesis (Shanghai) Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company 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