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DESyne® X2 Novolimus Eluting Coronary Stent System
EUDAMEDClass III (EU MDR)
Ref SZR3548
Identity
- Trade Name
- DESyne® X2 Novolimus Eluting Coronary Stent System EUDAMED
- Device Name
- DESyne® X2 Novolimus Eluting Coronary Stent System EUDAMED
- Model / Reference
- SZR3548 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SZR3548A6 EUDAMED
- Basic UDI-DI
- B-SZR3548A6 EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Sweden 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
DESyne® X2 Novolimus Eluting Coronary Stent System by Elixir Medical Corporation — 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-SZR3548A6 | Class III | Active |
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Manufacturer
- Manufacturer
- Elixir Medical Corporation
- EUDAMED SRN
- US-MF-000013041
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 955dff83-a0bc-4ef9-b248-296ecb07e78a 61 fields · synced Jul 29, 2026