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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Lombard Medical Limited

Certificate 170781682

Issued
Valid until
Dec 20, 2028

Certificate 170781682 is a valid Quality management system issued to Lombard Medical Limited and registered in EUDAMED. Valid until December 20, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number
170781682
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0297170781682

Validity

Issued
Dec 21, 2023
Valid from
Dec 21, 2023
Valid until
Dec 20, 2028

Notified body

Notified body
DQS Medizinprodukte GmbH
Notified body SRN
0297
Notified body country
Germany

Characteristics

Sterile
Yes
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

  • MDN 1101/A N Device category Non-active cardiovascular and vascular implants
    Class III
  • DEVICE
    Class III

Documents

LanguagesEN

Manufacturer

Manufacturer
Lombard Medical Limited
Manufacturer SRN
GB-MF-000014515
Manufacturer country
United Kingdom

Covered devices

  • Aorfix™ AAA Endovascular Stent Graft with Intelliflex™ Low Profile Delivery SystemClass III
    05055715AO01BU