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 - Datascope Corp.

Address:

15 Law Drive

Fairfield

07004

United States

Authorised Representative/ UK Responsible Person
Name: Getinge Ltd.
Address:

14-15 Burford Way Boldon Business Park

Boldon Colliery Tyne and Wear

Boldon

NE35 9PZ

England United Kingdom

Code/Term Type

Intra-aortic balloon catheter Intra-aortic balloon catheter Class IIa

Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Class IIa

Vascular catheter introduction set nonimplantable Vascular catheter introduction set nonimplantable Class IIa

Intra-aortic balloon pump Intra-aortic balloon pump Class IIb

Cardiac/peripheral vascular guidewire single-use Cardiac/peripheral vascular guidewire single-use Class III

Intra-aortic balloon catheter Intra-aortic balloon catheter Class III

Vascular catheter introduction set nonimplantable Vascular catheter introduction set nonimplantable Class III

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
Intra-aortic balloon catheter	Intra-aortic balloon catheter	Class IIa
Cardioplegia solution administration adaptor	Cardioplegia solution administration adaptor	Class IIa
Vascular catheter introduction set nonimplantable	Vascular catheter introduction set nonimplantable	Class IIa
Intra-aortic balloon pump	Intra-aortic balloon pump	Class IIb
Cardiac/peripheral vascular guidewire single-use	Cardiac/peripheral vascular guidewire single-use	Class III
Intra-aortic balloon catheter	Intra-aortic balloon catheter	Class III
Vascular catheter introduction set nonimplantable	Vascular catheter introduction set nonimplantable	Class III