Identity
- Device Name
- Guidewire J10-FC-260-035/PTFE-WE580 EUDAMED
- Model / Reference
- 44011643 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-440116437Y EUDAMED
- Basic UDI-DI
- B-440116437Y EUDAMED
- EMDN Code
- C0499 CARDIOVASCULAR GUIDEWIRES - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Guidewire J10-FC-260-035/PTFE-WE580 by Epflex Feinwerktechnik Gmbh — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-440116437Y | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EPflex Feinwerktechnik GmbH
- EUDAMED SRN
- DE-MF-000005425
Sources (1)
- EUDAMED fcd70deb-9d45-4c08-97b6-a8fe771bdbf3 61 fields · synced Jul 13, 2026