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 - Biosensors Europe SA

Address:

Rue de Lausanne 29

Morges

1110

Switzerland

Authorised Representative/ UK Responsible Person
Name: BIOSENSORS INTERNATIONAL UK LTD
Address:

12 NEW FETTER LANE

LONDON

EC4A1JP

England United Kingdom

Code/Term Type

Bare-metal coronary artery stent Bare-metal coronary artery stent Class III

Coronary angioplasty balloon catheter basic Coronary angioplasty balloon catheter basic Class III

Coronary angioplasty balloon catheter drug-coated Coronary angioplasty balloon catheter drug-coated Class III

Peripheral angioplasty balloon catheter drug-coated Peripheral angioplasty balloon catheter drug-coated Class III

Drug-eluting coronary artery stent bioabsorbable-polymer-coated Drug-eluting coronary artery stent bioabsorbable-polymer-coated Class III

Drug-coated-metal coronary artery stent Drug-coated-metal coronary artery stent 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
Bare-metal coronary artery stent	Bare-metal coronary artery stent	Class III
Coronary angioplasty balloon catheter basic	Coronary angioplasty balloon catheter basic	Class III
Coronary angioplasty balloon catheter drug-coated	Coronary angioplasty balloon catheter drug-coated	Class III
Peripheral angioplasty balloon catheter drug-coated	Peripheral angioplasty balloon catheter drug-coated	Class III
Drug-eluting coronary artery stent bioabsorbable-polymer-coated	Drug-eluting coronary artery stent bioabsorbable-polymer-coated	Class III
Drug-coated-metal coronary artery stent	Drug-coated-metal coronary artery stent	Class III