Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 181850. 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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

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

MHRA Device ID: 181850•Ref: 181850

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Nov 15, 2024

Last Updated

Nov 16, 2023

Manufacturer Information

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

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Igenesis (Shanghai) Co., Ltd. (10)

Other Products from Same Authorized Representative (10)

Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique

Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique

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

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

Thermal cycler nucleic acid amplification analyser IVD, laboratory

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

Magnetic particle separation instrument IVD

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

Human papillomavirus (HPV) nucleic acid IVD, probe

Human papillomavirus (HPV) nucleic acid IVD, probe

Limb tourniquet, manual, single-use

Glucose monitoring system IVD, home-use

Electric-motor-driven wheelchair, occupant-controlled

General-purpose surgical sponge

General-purpose surgical sponge

Radiopaque woven surgical sponge

Surgical/medical face mask, non-antimicrobial, single-use

Suture kit, non-medicated

Wound dressing kit, non-medicated

Cardiopulmonary resuscitation mouthpiece/cover