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Guidewires for Peripheral Application
EUDAMEDClass IIa (EU MDR)
Ref GWPTC-035-90-N_1
Identity
- Device Name
- Guidewires for Peripheral Application EUDAMED
- Model / Reference
- GWPTC-035-90-N_1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255605609066 EUDAMED
- Basic UDI-DI
- 42556056gwcIIaFP EUDAMED
- EMDN Code
- U0602 UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC 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
Guidewires for Peripheral Application 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 29b4b903-a7ab-4a1c-aa24-7f39d3f2dfe5 61 fields · synced Jun 19, 2026