Altura™ Endograft System With Delivery Catheter
Ref 01-AI-21-065Model 01-AA-24-090
Active
CE MDR CE MDD
Valid until
4 Sep 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number05055715AL01BD 05055715637831 | Date20 Nov 2024 | StatusActive |
| European Union | CE/MDR | Number05055715AL01BD 05055715637831 | Date20 Nov 2024 | StatusActive |
Certificates
- 1000170426 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 5 Sep 2024
- Expires
- 4 Sep 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device Name
- Altura™ Endograft System With Delivery CatheterAltura™ Endograft System With Delivery Catheter Gen 2.0
- Model / Reference
- 01-AA-24-090, 01-AI-21-065
- Primary DI / UDI-DI
- 05055715637831
- Basic UDI-DI
- 05055715AL01BD, B-05055715637831
- EMDN Code
- C019009 Aortic occlusion systems
- Device Class
- Class III
- EU market of registration
- LatviaGermany
Manufacturer details
- EUDAMED SRN
- GB-MF-000014515
- Authorised representative
- Medical Device Management Ltd IE-AR-000002496
Other devices from Lombard Medical Limited
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No