p48 LITE HPC Flow Modulation Device
Ref P48-LT-HPC-300-15Model Neurovascular Flow Diverter
Active
CE MDR
Valid until
20 Dec 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000332692 | Date4 Sep 2026 | StatusActive |
Certificates
- 1000266808 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 20 Nov 2025
- Expires
- 20 Dec 2028
- Reason
- Add device or group
- 1000332692 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 4 Sep 2026
- Expires
- 20 Dec 2028
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Neurovascular Flow Diverter, P48-LT-HPC-300-15
- Primary DI / UDI-DI
- 04260123785390
- Basic UDI-DI
- 426012378FlowDiverterSV
- EMDN Code
- P0704020202 Peripheral vascular coated stents
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006524
Other devices from phenox GmbH
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