United Kingdom MHRA device registration 114806

Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable

United Kingdom·General Medical Device·Gynesonics Inc.·Registered Nov 26, 2024

Registration details

Device ID: 114806
MHRA Reference Number: 114806
Date Registered: Nov 26, 2024
Last Updated: Aug 30, 2024

Device classification

Device Type: General Medical Device
Devices: Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable
Type: Class IIa

Manufacturer

Name: Gynesonics Inc.
Address: 600 Chesapeake Drive
Reedwood City, CA, United States
Created Date: Aug 16, 2021

Authorized Representative

Name: Obelis UK Ltd
Relationship Type: UK Responsible Person
Address: Sandford Gate, East Point Business Park
Oxford , England, United Kingdom
Postcode: OX4 6LB

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About this record

Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 114806. The device is manufactured by Gynesonics Inc. from United States, classified as General Medical Device. The authorized representative in the UK is Obelis UK Ltd.

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