Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 119125. The device is manufactured by Dynamiker Biotechnology (Tianjin) Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang 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

🇬🇧

Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 119125•Ref: 119125

Device Type

In Vitro Diagnostic Device

Devices

Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Sep 25, 2024

Manufacturer Information

Name

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Address

No.2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue, Sino-Singapore Eco-city, TEDA,

Tianjin, China

Created Date

Dec 10, 2021

Authorized Representative

Name

Wellkang Ltd

Relationship Type

UK Responsible Person

Address

16 Castle St.

Dover, Kent, England, United Kingdom

Postcode: CT16 1PW

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Dynamiker Biotechnology (Tianjin) Co., Ltd. (7)

Other Products from Same Authorized Representative (10)

Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA) - 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

Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)

1,3-Beta-D-glucan IVD, kit, enzyme spectrophotometry

Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Multichannel immunoassay analyser IVD

Assistive scooter, electric-motor-driven

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

Incontinence penis clamp, reusable

Manual goniometer

Continuous electronic patient thermometer, battery-powered

Nasal aspirator, manual

Nasal aspirator, manual

Nasal aspirator, manual

Nasal aspirator, manual

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical