Identity
- Trade Name
- GPS Wire EUDAMED
- Device Name
- Guidewires for Peripheral Application EUDAMED
- Model / Reference
- WIR1-J6-35-450 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255605608724 EUDAMED
- Basic UDI-DI
- 42556056gwcIIaFP 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
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
GPS Wire 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 (1)
- EUDAMED 5d2f4a72-e2b1-411f-ba60-8e9e1dde9024 61 fields · synced Jun 19, 2026