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ProxiCor for Pericardial Closure
EUDAMEDClass III (EU MDR)
Ref CMCV-118-402Ref CMCV-118-401
Identity
- Trade Name
- ProxiCor for Pericardial Closure EUDAMED
- Device Name
- ProxiCor for Pericardial Closure, Single Pack, 7 cm X 15 cm, OUS EUDAMEDProxiCor for Pericardial Closure, Single Pack, 7 cm X 10 cm, OUS EUDAMED
- Model / Reference
- CMCV-118-402 EUDAMEDCMCV-118-401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00859389005201 EUDAMED00859389005195 EUDAMED
- Basic UDI-DI
- B-00859389005201 EUDAMEDB-00859389005195 EUDAMED
- EMDN Code
- P07020101 PERICARDIUM VASCULAR PATCHES 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
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ProxiCor for Pericardial Closure by Aziyo Biologics, 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-00859389005201 | Class III | Active |
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Manufacturer
- Manufacturer
- Aziyo Biologics, Inc.
- EUDAMED SRN
- US-MF-000003634
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED d3449f48-3d22-4931-a76a-eef025be91d2 61 fields · synced Jul 26, 2026
- EUDAMED e29ba36c-a6ae-4644-80e1-bb00645611f4 61 fields · synced May 19, 2026