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p48 LITE HPC Flow Modulation Device
EUDAMEDClass III (EU MDR)
Ref P48-LT-HPC-200-15Model Neurovascular Flow DiverterRef P48-LT-HPC-300-18Ref P48-LT-HPC-250-9Ref P48-LT-HPC-250-18Ref P48-LT-HPC-300-15Ref P48-LT-HPC-250-12Ref P48-LT-HPC-300-12Ref P48-LT-HPC-200-12
by phenox GmbH
Identity
- Trade Name
- p48 LITE HPC Flow Modulation Device EUDAMED
- Model / Reference
- Neurovascular Flow Diverter EUDAMEDP48-LT-HPC-200-15 EUDAMEDP48-LT-HPC-300-18 EUDAMEDP48-LT-HPC-250-9 EUDAMEDP48-LT-HPC-250-18 EUDAMEDP48-LT-HPC-300-15 EUDAMEDP48-LT-HPC-250-12 EUDAMEDP48-LT-HPC-300-12 EUDAMEDP48-LT-HPC-200-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260123785321 EUDAMED04260123785406 EUDAMED04260123785338 EUDAMED04260123785369 EUDAMED04260123785390 EUDAMED04260123785345 EUDAMED04260123785383 EUDAMED04260123785314 EUDAMED
- Basic UDI-DI
- 426012378FlowDiverterSV EUDAMED
- EMDN Code
- P0704020202 PERIPHERAL VASCULAR COATED STENTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
p48 LITE HPC Flow Modulation Device by phenox GmbH — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426012378FlowDiverterSV | Class III | Active |
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Manufacturer
- Manufacturer
- phenox GmbH
- EUDAMED SRN
- DE-MF-000006524
Sources (8)
- EUDAMED c7b3df62-e873-40d9-ac84-9e1d5724332a 61 fields · synced Sep 18, 2026
- EUDAMED d47cf1e3-10e3-4601-9bec-374dc7bec145 61 fields · synced May 11, 2026
- EUDAMED cf89219a-7422-498e-b872-7fdc329915c8 61 fields · synced May 17, 2026
- EUDAMED 6ac0fec3-8520-4564-b438-dc019a7750b7 61 fields · synced May 17, 2026
- EUDAMED e92f19f1-a738-4d1a-8059-a5b56f9d7c92 61 fields · synced May 18, 2026
- EUDAMED cca8b0b3-d78c-4128-9a08-ecbe052cad2b 61 fields · synced May 18, 2026
- EUDAMED 02a772f1-00ac-407a-912b-8a1b36905d94 61 fields · synced May 18, 2026
- EUDAMED 7a7ed111-2844-47d8-9c75-9fc40e85c7d7 61 fields · synced May 18, 2026