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 - Terumo Cardiovascular Systems Corporation

Address:

125 Blue Ball Road

Elkton

Maryland 21921

United States

Authorised Representative/ UK Responsible Person
Name: Terumo UK Ltd
Address:

Otium House 2 Freemantle Road

Bagshot

Surrey GU19 5LL

England United Kingdom

Code/Term Type

Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Class III

Coronary artery exposure retractor Coronary artery exposure retractor Class IIa

Coronary artery exposure retractor Coronary artery exposure retractor Class IIa

Surgical instrument assist arm system manually-adjusted Surgical instrument assist arm system manually-adjusted Class I

Suture retention device Suture retention device Class I

Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor Class IIa

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Class IIa

Cardiotomy reservoir Cardiotomy reservoir Class IIa

Cardiopulmonary bypass system valve unidirectional flow/pressure control Cardiopulmonary bypass system valve unidirectional flow/pressure control Class IIa

Endoscopic electrosurgical electrode bipolar single-use Endoscopic electrosurgical electrode bipolar single-use Class IIb

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
Cardiopulmonary bypass system blood gas sensor	Cardiopulmonary bypass system blood gas sensor	Class III
Coronary artery exposure retractor	Coronary artery exposure retractor	Class IIa
Coronary artery exposure retractor	Coronary artery exposure retractor	Class IIa
Surgical instrument assist arm system manually-adjusted	Surgical instrument assist arm system manually-adjusted	Class I
Suture retention device	Suture retention device	Class I
Cardiopulmonary bypass system blood gas sensor	Cardiopulmonary bypass system blood gas sensor	Class IIa
Extracorporeal membrane oxygenator	Extracorporeal membrane oxygenator	Class IIa
Cardiotomy reservoir	Cardiotomy reservoir	Class IIa
Cardiopulmonary bypass system valve unidirectional flow/pressure control	Cardiopulmonary bypass system valve unidirectional flow/pressure control	Class IIa
Endoscopic electrosurgical electrode bipolar single-use	Endoscopic electrosurgical electrode bipolar single-use	Class IIb