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p48 LITE Flow Modulation Device
EUDAMEDClass III (EU MDR)
Ref P48-LT-200-12Model Neurovascular Flow DiverterRef P48-LT-250-15Ref P48-LT-300-15Ref P48-LT-300-12
by phenox GmbH
Identity
- Trade Name
- p48 LITE Flow Modulation Device EUDAMED
- Model / Reference
- Neurovascular Flow Diverter EUDAMEDP48-LT-200-12 EUDAMEDP48-LT-250-15 EUDAMEDP48-LT-300-15 EUDAMEDP48-LT-300-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260123785741 EUDAMED04260123785789 EUDAMED04260123785826 EUDAMED04260123785819 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
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 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 (4)
- EUDAMED aae1676f-b998-4488-9954-53d8afbdb798 61 fields · synced Jul 30, 2026
- EUDAMED bac7d90c-4b17-44bd-95b6-bf8160d80b88 61 fields · synced May 17, 2026
- EUDAMED 9c03c244-6178-4570-8702-cb0473dde6b4 61 fields · synced May 17, 2026
- EUDAMED 1af0f312-5239-4f87-a0e9-25f51dc11884 61 fields · synced May 18, 2026