United Kingdom MHRA device registration 125223

Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Seegene Inc.·Registered Nov 26, 2024

Registration details

Device ID: 125223
MHRA Reference Number: 125223
Date Registered: Nov 26, 2024
Last Updated: Nov 12, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: Seegene Inc.
Address: Taewon Bldg., 91, Ogeum-ro, Songpa-gu
Seoul, South Korea
Created Date: Aug 5, 2021

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

Multiple-type meningitis pathogen 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 125223. The device is manufactured by Seegene Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting Ltd.

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