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ELECTRO DETACH GENERATOR v4
EUDAMEDClass IIb (EU MDR)
Ref 347-404RModel ELECTRO DETACH GENERATOR v4Ref 347-404
Identity
- Trade Name
- ELECTRO DETACH GENERATOR v4 EUDAMED
- Model / Reference
- ELECTRO DETACH GENERATOR v4 EUDAMED347-404R EUDAMED347-404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778186330 EUDAMED04540778138797 EUDAMED
- Basic UDI-DI
- 4993478KNK0053Y EUDAMEDB-04540778138797 EUDAMED
- EMDN Code
- Z12109001 DETACHABLE COIL EQUIPMENT FOR BRAIN ANEURYSMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
ELECTRO DETACH GENERATOR v4 by KANEKA Corporation — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4993478KNK0053Y | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4993478KNK0053Y | Class IIb | 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 (2)
- EUDAMED b07dad47-c4ad-456c-95bb-127137416ba0 61 fields · synced Aug 3, 2026
- EUDAMED ca2d44e1-9d74-4284-9050-d97fd6ddb525 61 fields · synced May 18, 2026