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p64 Flow Modulation Device
EUDAMEDClass III (EU MDR)
Ref P64-500-18Model Neurovascular Flow Diverter
by phenox GmbH
Identity
- Trade Name
- p64 Flow Modulation Device EUDAMED
- Model / Reference
- Neurovascular Flow Diverter EUDAMEDP64-500-18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260123783396 EUDAMED
- Basic UDI-DI
- 426012378FlowDiverterSV EUDAMED
- EMDN Code
- P070402020102 NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL 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
No
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
p64 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 (1)
- EUDAMED 76136f5c-ed35-4d63-8e00-094f91ddad00 61 fields · synced Jun 19, 2026