Identity
- Trade Name
- Cocoon PFO Occluder EUDAMED
- Device Name
- Cocoon PFO Occluders EUDAMED
- Model / Reference
- CPF30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08858788500685 EUDAMED
- Basic UDI-DI
- B-08858788500685 EUDAMED
- EMDN Code
- P07040303 CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain 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
Cocoon PFO Occluder by Vascular Innovations Co. Ltd. — Class III — CE/MDR — 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-08858788500685 | Class III | Active |
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Manufacturer
- Manufacturer
- Vascular Innovations Co. Ltd.
- EUDAMED SRN
- TH-MF-000028144
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED fefdc9eb-1b56-4880-9cac-d74ad447e360 61 fields · synced Oct 6, 2026