Identity
- Trade Name
- ED COIL EUDAMED
- Device Name
- ED COIL EUDAMED
- Model / Reference
- 350-0308R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778142213 EUDAMED
- Basic UDI-DI
- B-04540778142213 EUDAMED
- EMDN Code
- C010402020301 EMBOLISATION COILS 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ed Coil by KANEKA Corporation — 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-04540778142213 | Class III | Active |
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Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (1)
- EUDAMED bc8bfb78-2ff2-414f-8419-dfec81b64674 61 fields · synced May 23, 2026