pCONUS2 HPC Bifurcation Aneurysm Implant
by phenox GmbH EUDAMED
Active
Ref PCON2-HPC-4-15-7Model Bifurcation Aneurysm Implant
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000332692 | Date4 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1000215968 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 3 Mar 2025
- Expires
- 2 Mar 2030
- 1000332692 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 4 Sep 2026
- Expires
- 20 Dec 2028
- Reason
- Change approved
Specification
- Model / Reference
- Bifurcation Aneurysm Implant, PCON2-HPC-4-15-7
- Primary DI / UDI-DI
- 04260123784591
- Basic UDI-DI
- 426012378BifurImplantGK
- EMDN Code
- P0704020202 Peripheral vascular coated stents
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006524
Other devices from phenox GmbH
Properties
Show properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No