Identity
- Device Name
- Guidewire SFCPH-450/5-035/NiTi EUDAMED
- Model / Reference
- 41010435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-410104355V EUDAMED
- Basic UDI-DI
- B-410104355V EUDAMED
- EMDN Code
- G030499 ERCP AND SPHINCTEROTOMY DEVICES - 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
Guidewire SFCPH-450/5-035/NiTi 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-410104355V | Class IIa | Active |
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Manufacturer
- Manufacturer
- EPflex Feinwerktechnik GmbH
- EUDAMED SRN
- DE-MF-000005425
Sources (1)
- EUDAMED e41856c6-b762-46d9-b3a7-cecfa40e96e8 61 fields · synced Jun 19, 2026