United Kingdom MHRA device registration 112046

Ribonucleoprotein antibody (anti-RNP) IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·ORGENTEC Diagnostika GmbH·Registered Nov 26, 2024

Registration details

Device ID: 112046
MHRA Reference Number: 112046
Date Registered: Nov 26, 2024
Last Updated: Jun 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Ribonucleoprotein antibody (anti-RNP) IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: ORGENTEC Diagnostika GmbH
Address: Carl-Zeiss-Str. 49-51
Mainz, Rheinhessen-Pfalz, Germany
Created Date: Aug 10, 2021

Authorized Representative

Name: Qarad UK Ltd.
Relationship Type: UK Responsible Person
Address: 8 Northumberland Ave
Westminster, London , England, United Kingdom
Postcode: WC2N 5BY

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About this record

Ribonucleoprotein antibody (anti-RNP) IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 112046. The device is manufactured by ORGENTEC Diagnostika GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK Ltd..

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