Identity
- Trade Name
- IMP PTFE-Führungsdraht EUDAMED
- Device Name
- Guidewires for Peripheral Application EUDAMED
- Model / Reference
- 139100035151 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255605602289 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-Führungsdraht 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 (1)
- EUDAMED c3559820-0310-4a40-badd-2a87eb8d1ede 61 fields · synced Jun 19, 2026