Identity
- Trade Name
- IASD System II EUDAMED
- Device Name
- IASD System II EUDAMED
- Model / Reference
- 00261 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00863788000446 EUDAMED
- Basic UDI-DI
- B-00863788000446 EUDAMED
- EMDN Code
- P0799 VASCULAR AND CARDIAC PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
IASD System II by Corvia Medical, 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-00863788000446 | Class III | Active |
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Manufacturer
- Manufacturer
- Corvia Medical, Inc.
- EUDAMED SRN
- US-MF-000024255
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED d1e4c5c3-3485-431b-a17e-b9ecd3c9d80b 61 fields · synced Jul 24, 2026