United Kingdom MHRA device registration 178801

Fluorescent immunoassay analyser IVD, point-of-care

United Kingdom·In Vitro Diagnostic Device·Suzhou Helmen Precision Instruments Co.,Ltd ·Registered Nov 26, 2024

Registration details

Device ID: 178801
MHRA Reference Number: 178801
Date Registered: Nov 26, 2024
Last Updated: Jun 25, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Fluorescent immunoassay analyser IVD, point-of-care
Type: IVD General

Manufacturer

Name: Suzhou Helmen Precision Instruments Co.,Ltd
Address: 4th Floor, Building 5, #8,JinFeng RD, High-tech Zone,
SuZhou, Jiangsu, China
Created Date: Sep 12, 2023

Authorized Representative

Name: lotus global co ltd
Relationship Type: UK Responsible Person
Address: 23 Maine Street
Reading, Reading, England, United Kingdom
Postcode: RG2 6AG

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About this record

Fluorescent immunoassay analyser IVD, point-of-care is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 178801. The device is manufactured by Suzhou Helmen Precision Instruments Co.,Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is lotus global co ltd.

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