Human genomic analysis interpretive software IVD - UK MHRA Medical Device Registration

Human genomic analysis interpretive software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 132212. The device is manufactured by BGI Europe A/S from Denmark, 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

🇬🇧

Human genomic analysis interpretive software IVD

MHRA Device ID: 132212•Ref: 132212

Device Type

In Vitro Diagnostic Device

Devices

Human genomic analysis interpretive software IVD

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 8, 2023

Manufacturer Information

Name

BGI Europe A/S

Address

Symfonivej 34

Herlev, Denmark

Created Date

Aug 30, 2021

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 BGI Europe A/S (10)

Other Products from Same Authorized Representative (10)

Human genomic analysis interpretive software IVD - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Multiple Salmonella species immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Interleukin-6 (IL-6) 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

Prolactin IVD, kit, fluorescent immunoassay

Nucleic acid sequencing reagent kit IVD

Human infectome analysis interpretive software IVD

Nucleic acid extraction/isolation kit IVD

Cancer-related multiple gene mutation profile kit IVD

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

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

Human genomic analysis interpretive software

Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer

Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry/liquid chromatography (LC/MS)

Nucleic acid library construction kit IVD

Intraoral optical scanning system

Pneumatic dental scaling/debridement system handpiece

Aerosol face mask, rebreathing, single-use

Basic endotracheal tube, single-use

Endobronchial tube

Laryngeal mask airway, single-use

Rebreathing oxygen face mask

Tracheostomy tube, non-reinforced, non-customized, single-use

Assistive scooter, electric-motor-driven

Intraoral camera