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DynamX Sirolimus Eluting Coronary Bioadaptor System
EUDAMEDClass III (EU MDR)
Ref VIR3038Ref VIR3038 Model VIR2014
Identity
- Trade Name
- DynamX Sirolimus Eluting Coronary Bioadaptor System EUDAMED
- Device Name
- DynamX Sirolimus Eluting Coronary Bioadaptor System EUDAMED
- Model / Reference
- VIR3038 EUDAMEDVIR2014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817508013025 EUDAMED
- Basic UDI-DI
- B-00817508013025 EUDAMED081750801DynamXVIR4F EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMEDP07040199 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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00817508013025 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00817508013025 | 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 (2)
- EUDAMED 70cf0392-ad6d-4faf-84d3-14d1cef79dc0 61 fields · synced Jul 12, 2026
- EUDAMED 730bc3b0-05bc-464d-af26-24ff3cc2e945 61 fields · synced May 19, 2026