SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

SARS-CoV-2 nucleic acid 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 101566. The device is manufactured by Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch from Taiwan, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Advena 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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 101566•Ref: 101566

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 8, 2024

Manufacturer Information

Name

Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch

Address

(Building D) 15F., No.93, Sec.1, Xintai 5th Road

New taipei city , Xizhi District, Taiwan

Created Date

Aug 31, 2021

Authorized Representative

Name

Advena Ltd

Relationship Type

UK Responsible Person

Address

Pure Offices Plato Close

Warwick, England, United Kingdom

Postcode: CV34 6WE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch (8)

Other Products from Same Authorized Representative (10)

SARS-CoV-2 nucleic acid 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

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

SARS-CoV-2 nucleic acid IVD, control

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Influenza A/B virus nucleic acid IVD, control

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Respiratory syncytial virus (RSV) nucleic acid IVD, control

Ferritin IVD, kit, rapid ICT, clinical

Surgical instrument/endoscope cleaning utensil, single-use

Clavicle orthosis

Hand/finger splint, reusable

Hip orthosis

Shoulder immobilizer/orthosis, reusable

Skin-cover adhesive strip, non-antimicrobial

Thoracic spine orthosis

Thoracolumbosacral spine orthosis, rigid

Cystatin C IVD, kit, rapid ICT, clinical