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EUDAMED registration 05055715632829No

Aorfix™ AAA Endovascular Stent Graft with Intelliflex™ Low Profile Delivery System

Lombard Medical LimitedClass IIIEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class III
CND nomenclatures code
C019009
Implantable
Yes
Reusable
No
Measuring function
No
Registration information
Primary DI
05055715632829
Basic UDI
B-05055715632829
Version date
November 10, 2022
Manufacturer last update
November 25, 2022
Active status
No
Manufacturer
Manufacturer name
Lombard Medical Limited
Country
United Kingdom (ex Northern Ireland)
Country type
NON_EU
Address
4 Trident Park Didcot
Email
compliance@Lombardmedical.com
Authorized representative
Name
Medical Device Management Ltd
SRN
IE-AR-000002496
Country
Ireland
Address
Block B, The Crescent Building, Dublin 9
Email
EU-Rep@medicaldevicemanagement.com
Telephone
+353 (0) 1893 4143
Regulatory information
Competent authority
DE/CA304 - Marktüberwachung Medizinprodukte Bayern
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Spain
Market available
Austria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Finland:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Ireland:None~None, Italy:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Romania:None~None, Slovakia:None~None, Spain:None~None, Sweden:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

AORTIC OCCLUSION SYSTEMS

About this record

Access comprehensive regulatory information for Aorfix™ AAA Endovascular Stent Graft with Intelliflex™ Low Profile Delivery System in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 05055715632829 and manufactured by Lombard Medical Limited in United Kingdom (ex Northern Ireland).

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA304 - Marktüberwachung Medizinprodukte Bayern), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.