Identity
- Trade Name
- Cocoon EUDAMED
- Device Name
- Accessory Sets for Septal Occluder EUDAMED
- Model / Reference
- COA10F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08858788500388 EUDAMED
- Basic UDI-DI
- B-08858788500388 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Category: Vascular catheter introduction set, nonimplantable
Cocoon by Vascular Innovations Co. Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08858788500388 | 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 a530fcd6-7a78-4143-b213-1df379f82e22 61 fields · synced Oct 6, 2026