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p64 Flow Modulation Device
EUDAMEDClass III (EU MDR)
Ref P64-500-36Model Neurovascular Flow DiverterRef P64-450-15Ref P64-350-21Ref P64-400-21Ref P64-300-12Ref P64-450-27Ref P64-500-30Ref P64-400-27Ref P64-400-24Ref P64-350-15Ref p64-250-9Ref P64-300-9Ref P64-400-15Ref P64-450-18Ref P64-350-18
by phenox GmbH
Identity
- Trade Name
- p64 Flow Modulation Device EUDAMED
- Model / Reference
- Neurovascular Flow Diverter EUDAMEDP64-500-36 EUDAMEDP64-450-15 EUDAMEDP64-350-21 EUDAMEDP64-400-21 EUDAMEDP64-300-12 EUDAMEDP64-450-27 EUDAMEDP64-500-30 EUDAMEDP64-400-27 EUDAMEDP64-400-24 EUDAMEDP64-350-15 EUDAMEDp64-250-9 EUDAMEDP64-300-9 EUDAMEDP64-400-15 EUDAMEDP64-450-18 EUDAMEDP64-350-18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260123783426 EUDAMED04260123783341 EUDAMED04260123783273 EUDAMED04260123783310 EUDAMED04260123783211 EUDAMED04260123783389 EUDAMED04260123783419 EUDAMED04260123783334 EUDAMED04260123783327 EUDAMED04260123783259 EUDAMED04260123783198 EUDAMED04260123783204 EUDAMED04260123783297 EUDAMED04260123783358 EUDAMED04260123783266 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 (15)
- EUDAMED 2e93ed4b-4b53-46ea-96ed-24762647425b 61 fields · synced Sep 18, 2026
- EUDAMED 7a7c993c-4233-486d-9d75-1c93fec666ea 61 fields · synced May 16, 2026
- EUDAMED 9460d900-f5f9-45b4-8824-76e3221f1dfd 61 fields · synced May 16, 2026
- EUDAMED 15313d6f-e40d-4bba-aa98-ce3d85526abc 61 fields · synced May 17, 2026
- EUDAMED 477cf1fc-57f8-4d38-a9e7-5f4215fe9baf 61 fields · synced May 17, 2026
- EUDAMED b5a02742-e9dd-4443-a8ba-8fa7b3d43241 61 fields · synced May 17, 2026
- EUDAMED 58a3e094-3e19-4191-841f-b0e2cd55e554 61 fields · synced May 18, 2026
- EUDAMED 90fb1396-3c6e-4faf-9a10-23def6e59bb6 61 fields · synced May 18, 2026
- EUDAMED e772575a-f803-4615-b7ae-8ec5bbbc67a2 61 fields · synced May 18, 2026
- EUDAMED 347d3224-ec44-4307-8087-06443a7d4f4d 61 fields · synced May 18, 2026
- EUDAMED 14500ad4-e8b2-4ea0-975e-319a2c09f536 61 fields · synced May 18, 2026
- EUDAMED 4050f3b6-d611-47ec-b164-af3089771eb2 61 fields · synced May 18, 2026
- EUDAMED a01b8f14-716c-44dc-987a-5c2630d06295 61 fields · synced May 18, 2026
- EUDAMED 6935ab75-2b56-46b4-8c81-a9ed2c1ac86c 61 fields · synced May 18, 2026
- EUDAMED d73b9ffc-9b26-433c-b693-8173596663bd 61 fields · synced May 19, 2026