United Kingdom MHRA device registration 197774

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, probe

United Kingdom·In Vitro Diagnostic Device·ZytoVision GmbH·Registered Nov 22, 2024

Registration details

Device ID: 197774
MHRA Reference Number: 197774
Date Registered: Nov 22, 2024
Last Updated: Jul 30, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, probe
Type: Class C

Manufacturer

Name: ZytoVision GmbH
Address: Fischkai 1
Bremerhaven, Germany
Created Date: Jul 26, 2024

Authorized Representative

Name: Emergo Consulting (UK) Limited
Relationship Type: UK Responsible Person
Address: Compass House, Vision Park Histon c/o Cr360 – UL International
Cambridge, England, United Kingdom
Postcode: CB24 9BZ

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About this record

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, probe is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 197774. The device is manufactured by ZytoVision GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) Limited .

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