United Kingdom MHRA device registration 190543

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent

United Kingdom·In Vitro Diagnostic Device·TS Diagnostics Sdn Bhd Company·Registered Nov 19, 2024

Registration details

Device ID: 190543
MHRA Reference Number: 190543
Date Registered: Nov 19, 2024
Last Updated: Apr 17, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent
Type: IVD General

Manufacturer

Name: TS Diagnostics Sdn Bhd Company
Address: No. 9, Jalan TPP 5/11, Taman Perindustrian Puchong 47160 Selangor, Malaysia
Selangor, Malaysia
Created Date: Apr 3, 2024

Authorized Representative

Name: Atlas Medical
Relationship Type: UK Responsible Person
Address: William James House Cowley Road
Cambridge, United Kingdom
Postcode: CB4 0WX

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About this record

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 190543. The device is manufactured by TS Diagnostics Sdn Bhd Company from Malaysia, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Atlas Medical.

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