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 - ACIST Medical Systems Inc.

Address:

7905 Fuller Road 7905 Fuller Road Eden Prairie

Minnesota

55344

United States

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

Magdalene Centre The Oxford Science Park

Oxford

OX4 4GA

England United Kingdom

Code/Term Type

Contrast medium injection system syringe Contrast medium injection system syringe Class IIa

Contrast medium injection system administration set Contrast medium injection system administration set Class IIa

Contrast medium injection system hand controller kit Contrast medium injection system hand controller kit Class IIa

Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Class IIa

Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Class IIa

Catheter-tip transducer pressure Catheter-tip transducer pressure Class III

Intravascular ultrasound imaging catheter single-use Intravascular ultrasound imaging catheter single-use Class III

Angiography contrast medium injection system line-powered mobile Angiography contrast medium injection system line-powered mobile 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
Contrast medium injection system syringe	Contrast medium injection system syringe	Class IIa
Contrast medium injection system administration set	Contrast medium injection system administration set	Class IIa
Contrast medium injection system hand controller kit	Contrast medium injection system hand controller kit	Class IIa
Cardiovascular ultrasound imaging system	Cardiovascular ultrasound imaging system	Class IIa
Cardiac catheterization laboratory computer	Cardiac catheterization laboratory computer	Class IIa
Catheter-tip transducer pressure	Catheter-tip transducer pressure	Class III
Intravascular ultrasound imaging catheter single-use	Intravascular ultrasound imaging catheter single-use	Class III
Angiography contrast medium injection system line-powered mobile	Angiography contrast medium injection system line-powered mobile	Class IIb