Identity
- Trade Name
- Dashwire EUDAMED
- Device Name
- Guidewires for Peripheral Application EUDAMED
- Model / Reference
- 41013182 EUDAMED41013178 EUDAMED41013179 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255605607420 EUDAMED04255605607406 EUDAMED04255605607468 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
Dashwire 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 (3)
- EUDAMED bce10cc4-eebd-4d4f-b760-96030f52f1d7 61 fields · synced Jul 30, 2026
- EUDAMED 824bb6b4-fc09-4b08-b977-916b4ab12617 61 fields · synced May 17, 2026
- EUDAMED 5fad11c8-04dc-4858-80c9-d595e4bee171 61 fields · synced May 18, 2026