United Kingdom MHRA device registration 119125

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

United Kingdom·In Vitro Diagnostic Device·Dynamiker Biotechnology (Tianjin) Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 119125
MHRA Reference Number: 119125
Date Registered: Nov 26, 2024
Last Updated: Sep 25, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

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

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About this record

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.

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