Identity
- Trade Name
- Extra Aortic EUDAMED
- Device Name
- Extra Aortic Annuloplasty Ring 33 mm EUDAMED
- Model / Reference
- 1100307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10627843217890 EUDAMED
- Basic UDI-DI
- B-10627843217890 EUDAMED
- EMDN Code
- P07030401 FLEXIBLE OR UNSUPPORTED HEART VALVE RINGS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Extra Aortic by Coroneo Inc — 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-10627843217890 | Class III | Active |
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Manufacturer
- Manufacturer
- Coroneo Inc.
- EUDAMED SRN
- CA-MF-000019141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 8782a6d7-ccef-45e6-bff2-c372867b0b22 61 fields · synced Jun 18, 2026