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Carillon Mitral Contour System (CMCS)
EUDAMEDClass III (EU MDR)
Ref CAT-1515-15
Identity
- Trade Name
- Carillon Mitral Contour System (CMCS) EUDAMED
- Device Name
- Carillon Mitral Contour System EUDAMED
- Model / Reference
- CAT-1515-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00819833020143 EUDAMED
- Basic UDI-DI
- 081983302CarillonB5 EUDAMED
- EMDN Code
- P0799 VASCULAR AND CARDIAC PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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
No
EUDAMED
Carillon Mitral Contour System (CMCS) by Cardiac Dimensions, Inc. — 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 | 081983302CarillonB5 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiac Dimensions, Inc.
- EUDAMED SRN
- US-MF-000002426
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 22a5b690-db9d-447e-8d94-85791774ba1e 61 fields · synced Jun 18, 2026