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 - JenaValve Technology Inc.

Address:

4 Cromwell

Irvine CA

92618

United States

Authorised Representative/ UK Responsible Person
Name: MDSS-UK RP LIMITED
Address:

6 Wilmslow Road Rusholme

Manchester

M14 5TP

England United Kingdom

Code/Term Type

Vascular guide-catheter single-use Vascular guide-catheter single-use Class III

Aortic transcatheter heart valve bioprosthesis stent-like framework Aortic transcatheter heart valve bioprosthesis stent-like framework 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
Vascular guide-catheter single-use	Vascular guide-catheter single-use	Class III
Aortic transcatheter heart valve bioprosthesis stent-like framework	Aortic transcatheter heart valve bioprosthesis stent-like framework	Class III