Identity
- Device Name
- Gudewire 50mm Radiopaque tip EUDAMED
- Model / Reference
- GW480-035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GW480-035NJ EUDAMED
- Basic UDI-DI
- B-GW480-035NJ EUDAMED
- EMDN Code
- C0499 CARDIOVASCULAR GUIDEWIRES - OTHER 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
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
Gudewire 50mm Radiopaque tip by Epflex Feinwerktechnik Gmbh — Class IIa — 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-GW480-035NJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- EPflex Feinwerktechnik GmbH
- EUDAMED SRN
- DE-MF-000005425
Sources (1)
- EUDAMED 077afea2-9826-47de-9195-a13eb05a6bf5 61 fields · synced Jul 21, 2026