United Kingdom MHRA device registration 201622

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Bosch Healthcare Solutions GmbH ·Registered Nov 26, 2024

Registration details

Device ID: 201622
MHRA Reference Number: 201622
Date Registered: Nov 26, 2024
Last Updated: May 3, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: Class C

Manufacturer

Name: Bosch Healthcare Solutions GmbH
Address: Stuttgarter Str. 130
Waiblingen, Germany
Created Date: Jul 5, 2023

Authorized Representative

Name: MT Promedt Consulting Ltd
Relationship Type: UK Responsible Person
Address: Beaver House, 23-38 Hythe Bridge Street
Oxford, England, United Kingdom
Postcode: OX1 2EP

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About this record

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 201622. The device is manufactured by Bosch Healthcare Solutions GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting Ltd.

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