Identity
- Trade Name
- eucaLimus EUDAMED
- Device Name
- eucaLimus Coronary Stent System with Sirolimus Drug Coating EUDAMED
- Model / Reference
- ELM30013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251895600462 EUDAMED
- Basic UDI-DI
- B-04251895600462 EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Yes
EUDAMED
The eucaLimus coronary stent system with sirolimus drug coating offers a unique combination of sterility, biocompatibility, and controlled release for the treatment of acute myocardial infarction.
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-04251895600462 | Class III | Active |
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Manufacturer
- Manufacturer
- eucatech AG
- EUDAMED SRN
- DE-MF-000005541
Sources (1)
- EUDAMED 04510a30-8937-4134-b09f-e168e10ee32d 61 fields · synced Jul 7, 2026