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pRESET STANDARD Thrombectomy Device
EUDAMEDClass III (EU MDR)
Ref PRE-4-20Model Thrombectomy SystemsRef PRES-6-50Ref PRE-6-30Ref PRES-5-40
by phenox GmbH
Identity
- Trade Name
- pRESET STANDARD Thrombectomy Device EUDAMED
- Model / Reference
- Thrombectomy Systems EUDAMEDPRE-4-20 EUDAMEDPRES-6-50 EUDAMEDPRE-6-30 EUDAMEDPRES-5-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260123784058 EUDAMED04260123784140 EUDAMED04260123784119 EUDAMED04260123784089 EUDAMED
- Basic UDI-DI
- 426012378ThrombectomyF6 EUDAMED
- EMDN Code
- C010402020702 MECHANICAL PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
pRESET STANDARD Thrombectomy 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 | 426012378ThrombectomyF6 | Class III | Active |
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Manufacturer
- Manufacturer
- phenox GmbH
- EUDAMED SRN
- DE-MF-000006524
Sources (5)
- EUDAMED 1d6ef981-3580-42c0-825a-bdf019d6580f 61 fields · synced Aug 2, 2026
- EUDAMED fbd4848c-c723-4d7d-afd6-220436da3550 61 fields · synced Jun 18, 2026
- EUDAMED 6be16c94-1ca0-4647-8c2d-8f1f1ecca34c 61 fields · synced Jul 13, 2026
- EUDAMED 542604f3-734b-4f19-bc80-70b0a71109f5 61 fields · synced Aug 1, 2026
- EUDAMED 6209a4e6-d8be-481b-9f24-170d60e760f4 61 fields · synced Aug 2, 2026