Identity
- Device Name
- MR-Guide R2 AFCPH-260/14-035 EUDAMED
- Model / Reference
- 49012876 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-49012876BM EUDAMED
- Basic UDI-DI
- B-49012876BM 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
MR-Guide R2 AFCPH-260/14-035 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-49012876BM | Class III | Active |
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Manufacturer
- Manufacturer
- EPflex Feinwerktechnik GmbH
- EUDAMED SRN
- DE-MF-000005425
Sources (1)
- EUDAMED 24cd00bd-a381-4345-aa6a-8182a7d46184 61 fields · synced Jun 19, 2026