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 - Hitachi Ltd

Address:

2-16-1

Higashiueno Taito-Ku

Tokyo

110-0015

Japan

Authorised Representative/ UK Responsible Person
Name: FUJIFILM Healthcare UK Ltd
Address:

FUJIFILM House Whitbread Way

Bedford

Bedford MK42 0ZE

England United Kingdom

Code/Term Type

General-purpose ultrasound imaging system General-purpose ultrasound imaging system Class IIa

Extracorporeal ultrasound imaging transducer hand-held Extracorporeal ultrasound imaging transducer hand-held Class IIa

Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Class IIa

Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Class IIa

Oesophageal ultrasound imaging transducer reusable Oesophageal ultrasound imaging transducer reusable 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
General-purpose ultrasound imaging system	General-purpose ultrasound imaging system	Class IIa
Extracorporeal ultrasound imaging transducer hand-held	Extracorporeal ultrasound imaging transducer hand-held	Class IIa
Surgical ultrasound imaging transducer	Surgical ultrasound imaging transducer	Class IIa
Rectal/vaginal ultrasound imaging transducer	Rectal/vaginal ultrasound imaging transducer	Class IIa
Oesophageal ultrasound imaging transducer reusable	Oesophageal ultrasound imaging transducer reusable	Class IIa