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DynamX Novolimus Eluting Coronary Bioadaptor System
EUDAMEDClass III (EU MDR)
Ref VCR2248
Identity
- Trade Name
- DynamX Novolimus Eluting Coronary Bioadaptor System EUDAMED
- Device Name
- DynamX Novolimus Eluting Coronary Bioadaptor System EUDAMED
- Model / Reference
- VCR2248 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VCR2248ZM EUDAMED
- Basic UDI-DI
- B-VCR2248ZM 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
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
DynamX Novolimus Eluting Coronary Bioadaptor 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-VCR2248ZM | 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 4bc4724b-993d-435f-9533-014ea261d1c6 61 fields · synced Jul 25, 2026