Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Focus Surgery Inc.

Address:

4000 Pendleton Way

Indianapolis

Indiana 46226

United States

Authorised Representative/ UK Responsible Person
Name: UKCApartner4U Limited
Address:

7 CAMPION WAY

BINGHAM NOTTINGHAM

NG13 8 TR

England United Kingdom

Code/Term Type

Ultrasonic hyperthermia system Ultrasonic hyperthermia system Class IIb

Invasive ultrasound transducer cooling/coupling support kit Invasive ultrasound transducer cooling/coupling support kit Class IIa

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Ultrasonic hyperthermia system	Ultrasonic hyperthermia system	Class IIb
Invasive ultrasound transducer cooling/coupling support kit	Invasive ultrasound transducer cooling/coupling support kit	Class IIa