United Kingdom MHRA device registration 92718

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

United Kingdom·In Vitro Diagnostic Device·Shenzhen New Industries Biomedical Engineering Co., Ltd. ·Registered Apr 11, 2024

Registration details

Device ID: 92718
MHRA Reference Number: 92718
Date Registered: Apr 11, 2024
Last Updated: Jan 16, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Type: IVD Annex II List B

Manufacturer

Name: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Address: No.23, Jinxiu East Road, Pingshan District
Shenzhen, China
Created Date: Aug 6, 2021

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

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 92718. The device is manufactured by Shenzhen New Industries Biomedical Engineering 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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