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Guidewires for Central Circulatory Application
EUDAMEDClass III (EU MDR)
Ref AU-035-300-C
Identity
- Device Name
- Guidewires for Central Circulatory Application EUDAMED
- Model / Reference
- AU-035-300-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255605601183 EUDAMED
- Basic UDI-DI
- 42556056gwcIIIEH 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
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 Central Circulatory Application by Epflex Feinwerktechnik Gmbh — Class III — 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 | 42556056gwcIIIEH | Class III | Active |
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Manufacturer
- Manufacturer
- EPflex Feinwerktechnik GmbH
- EUDAMED SRN
- DE-MF-000005425
Sources (1)
- EUDAMED 7f2f3453-c3da-463d-b0d0-e6e5af6e965a 61 fields · synced Jul 29, 2026