United Kingdom MHRA device registration 160401

Conjugated (direct) bilirubin IVD, reagent

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Zhejiang PushKang Biotechnology Co., Ltd.·Registered Oct 29, 2024
Registration details
Device ID
160401
MHRA Reference Number
160401
Date Registered
Oct 29, 2024
Last Updated
Oct 8, 2023
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Conjugated (direct) bilirubin IVD, reagent
Type
IVD General
Manufacturer
Address
C408, Science and Technology Innovation Park No. 398, Mahuan Road, Binhai New Area, Shaoxing
Zhejiang Province, China
Created Date
Nov 11, 2022
Authorized Representative
Relationship Type
UK Responsible Person
Address
3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR
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About this record

Conjugated (direct) bilirubin IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 160401. The device is manufactured by Zhejiang PushKang Biotechnology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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