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DynamX Sirolimus Eluting Coronary Bioadaptor System
EUDAMEDClass III (EU MDR)
Ref VIR2723Model VIR2014
Identity
- Trade Name
- DynamX Sirolimus Eluting Coronary Bioadaptor System EUDAMED
- Device Name
- DynamX Sirolimus Eluting Coronary Bioadaptor System EUDAMED
- Model / Reference
- VIR2014 EUDAMEDVIR2723 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817508012936 EUDAMED
- Basic UDI-DI
- 081750801DynamXVIR4F EUDAMED
- EMDN Code
- P07040199 VASCULAR ENDOPROSTHESES - OTHER 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
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
Yes
EUDAMED
DynamX Sirolimus Eluting Coronary Bioadaptor System by Elixir Medical Corporation — 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 | 081750801DynamXVIR4F | 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 c7ed5120-5701-4680-8f36-0cbfac5dfe16 61 fields · synced Jun 19, 2026