Covered Mounted CP Stent
Ref CMCP026Model 428.1
Active
CE MDR CE MDD
Valid until
23 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberUS26/00000111 | Date7 Sep 2026 | StatusActive |
| European Union | CE/MDD | NumberB-10887714027595 10887714027595 | Date21 Feb 2022 | StatusActive |
Certificates
- US26/00000111 Active
Technical documentation EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 7 Sep 2026
- Expires
- 23 Mar 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Model / Reference
- 428.1, CMCP026
- Primary DI / UDI-DI
- 10887714027595
- Basic UDI-DI
- B-10887714027595, 08877141660TL
- EMDN Code
- P070401020199 Ptfe vascular endoprostheses, straight - other
- Device Class
- Class III
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000010948
- Authorised representative
- EVOMED S.L.U. ES-AR-000047116
Other devices from NuMED, Inc.
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