Identity
- Trade Name
- Nuflex EUDAMED
- Device Name
- Guidewires for Peripheral Application EUDAMED
- Model / Reference
- 41013248 EUDAMED49012815 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255605603866 EUDAMED04255605603828 EUDAMED
- Basic UDI-DI
- 42556056gwcIIaFP EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa 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
Nuflex 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 c0e8e0c8-10b9-48f4-bb91-14a13b9bf2fc 61 fields · synced Jul 16, 2026
- EUDAMED f31e3d8a-e457-4b19-a80d-451542c796cd 61 fields · synced May 16, 2026