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 - QURA s.r.l.

Address:

via di Mezzo 23

Mirandola

Modena 41037

Italy

Authorised Representative/ UK Responsible Person
Name: Spectrum Medical Ltd
Address:

Harrier 4 Meteor Business Park Cheltenham Road East

Gloucester

Gloucestershire GL2 9QL

United Kingdom

Code/Term Type

Cardiopulmonary bypass system heat exchanger single-use Cardiopulmonary bypass system heat exchanger single-use Class IIa

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Class IIa

Cardiopulmonary bypass system centrifugal pump/heat exchanger Cardiopulmonary bypass system centrifugal pump/heat exchanger Class IIa

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator 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
Cardiopulmonary bypass system heat exchanger single-use	Cardiopulmonary bypass system heat exchanger single-use	Class IIa
Cardiopulmonary bypass system centrifugal pump	Cardiopulmonary bypass system centrifugal pump	Class IIa
Cardiopulmonary bypass system centrifugal pump/heat exchanger	Cardiopulmonary bypass system centrifugal pump/heat exchanger	Class IIa
Extracorporeal membrane oxygenator	Extracorporeal membrane oxygenator	Class IIa