United Kingdom MHRA device registration 81528

Hand-held-detector nuclear medicine system

United Kingdom·General Medical Device·Faxitron Bioptics, LLC (A Hologic Company)·Registered Nov 26, 2024

Registration details

Device ID: 81528
MHRA Reference Number: 81528
Date Registered: Nov 26, 2024
Last Updated: Feb 27, 2024

Device classification

Device Type: General Medical Device
Devices: Hand-held-detector nuclear medicine system
Type: Class IIa

Manufacturer

Name: Faxitron Bioptics, LLC (A Hologic Company)
Address: 250 Campus Drive
Marlborough, Massachusetts, United States
Created Date: May 19, 2021

Authorized Representative

Name: Hologic Ltd.
Relationship Type: UK Responsible Person
Address: Heron House 6 The Oaks Business Park Crewe Road Wythenshawe
Manchester, Lancashire, England, United Kingdom
Postcode: M23 9HZ

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About this record

Hand-held-detector nuclear medicine system is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 81528. The device is manufactured by Faxitron Bioptics, LLC (A Hologic Company) from United States, classified as General Medical Device. The authorized representative in the UK is Hologic Ltd..

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