United Kingdom MHRA device registration 95027

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Roche Sequencing Solutions, Inc.·Registered Sep 1, 2024

Registration details

Device ID: 95027
MHRA Reference Number: 95027
Date Registered: Sep 1, 2024
Last Updated: Jul 10, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)
Type: IVD Annex II List B

Manufacturer

Name: Roche Sequencing Solutions, Inc.
Address: 4300 Hacienda Dr.
Pleasanton, United States
Created Date: Aug 16, 2021

Authorized Representative

Name: Roche Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Roche Diagnostics Limited Charles Avenue
Burgess Hill, West Sussex, United Kingdom
Postcode: RH15 9RY

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About this record

Multiple congenital aneuploidy screening 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 95027. The device is manufactured by Roche Sequencing Solutions, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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