United Kingdom MHRA device registration 173372

Neuron-specific enolase (NSE) IVD, kit, chemiluminescent immunoassay

United Kingdom·In Vitro Diagnostic Device·Shenzhen Kinghi Biotechnology Co., Ltd.·Registered May 24, 2024

Registration details

Device ID: 173372
MHRA Reference Number: 173372
Date Registered: May 24, 2024
Last Updated: Mar 13, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Neuron-specific enolase (NSE) IVD, kit, chemiluminescent immunoassay
Type: IVD General

Manufacturer

Name: Shenzhen Kinghi Biotechnology Co., Ltd.
Address: 3B-1601, building 3, hengtaiyu building, Tangwei community, Fenghuang street, Guangming District
Shenzhen, China
Created Date: Jun 2, 2023

Authorized Representative

Name: SUNGO Certification Company Limited
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

Neuron-specific enolase (NSE) IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 173372. The device is manufactured by Shenzhen Kinghi 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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