Identity
- Device Name
- AndraGuide .035 flex 15 260 J3 EUDAMED
- Model / Reference
- 48012480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-48012480A7 EUDAMED
- Basic UDI-DI
- B-48012480A7 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
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
AndraGuide .035 flex 15 260 J3 by Epflex Feinwerktechnik Gmbh — Class III — 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-48012480A7 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EPflex Feinwerktechnik GmbH
- EUDAMED SRN
- DE-MF-000005425
Sources (1)
- EUDAMED a5b6f1fa-14b9-4805-b2d8-dfec19e380e3 61 fields · synced Jul 14, 2026