Identity
- Trade Name
- IMP PTFE Guidewire EUDAMED
- Device Name
- Guidewires for Peripheral Application EUDAMED
- Model / Reference
- 139700035150 EUDAMED139701035150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255605603262 EUDAMED04255605603286 EUDAMED
- Basic UDI-DI
- 42556056gwcIIaFP EUDAMED
- EMDN Code
- U0602 UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa 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
IMP PTFE Guidewire by Epflex Feinwerktechnik Gmbh — Class IIa — 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 | 42556056gwcIIaFP | Class IIa | Active |
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Manufacturer
- Manufacturer
- EPflex Feinwerktechnik GmbH
- EUDAMED SRN
- DE-MF-000005425
Sources (2)
- EUDAMED 302faf12-23aa-490d-82e5-ee976e0b47a9 61 fields · synced Jul 28, 2026
- EUDAMED e71c2978-0f21-4862-934e-0786a62f8353 61 fields · synced May 17, 2026