Thermal cycler nucleic acid amplification analyser IVD, laboratory - UK MHRA Medical Device Registration

Thermal cycler nucleic acid amplification analyser IVD, laboratory is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 188942. The device is manufactured by Biocartis NV from Belgium, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) 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

🇬🇧

Thermal cycler nucleic acid amplification analyser IVD, laboratory

MHRA Device ID: 188942•Ref: 188942

Device Type

In Vitro Diagnostic Device

Devices

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Type

Class A

Date Registered

Nov 26, 2024

Last Updated

Apr 17, 2024

Manufacturer Information

Name

Biocartis NV

Address

Generaal De Wittelaan 11 B

Mechelen, Belgium

Created Date

Dec 28, 2021

Authorized Representative

Name

Emergo Consulting (UK) Limited

Relationship Type

UK Responsible Person

Address

Compass House, Vision Park Histon c/o Cr360 – UL International

Cambridge, England, United Kingdom

Postcode: CB24 9BZ

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Biocartis NV (9)

Other Products from Same Authorized Representative (10)

Thermal cycler nucleic acid amplification analyser IVD, laboratory - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Legionella pneumophila 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

Clostridium difficile antigen IVD, kit, rapid ICT, clinical

NRAS gene mutation IVD, kit, nucleic acid technique (NAT)

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

KRAS gene mutation IVD, kit, nucleic acid technique (NAT)

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Microsatellite instability IVD, kit, nucleic acid technique (NAT)

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Cancer-related multiple gene mutation profile kit IVD

BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Arthrodesis nail

Bone distraction forceps

Bone fixation plate pliers insert

External orthopaedic fixation system, single-use

Fluted surgical drill bit, single-use

External orthopaedic fixation system, single-use

External orthopaedic fixation system, single-use

Fluted surgical drill bit, reusable

Fluted surgical drill bit, single-use

Bone nail guidewire, reusable