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IKAZUCHI Zero
EUDAMEDClass III (EU MDR)
Ref ZE-15-375Model Kaneka PTCA Balloon Dilatation Catheters
Identity
- Trade Name
- IKAZUCHI Zero EUDAMED
- Device Name
- IKAZUCHI Zero EUDAMED
- Model / Reference
- Kaneka PTCA Balloon Dilatation Catheters EUDAMEDZE-15-375 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778150195 EUDAMED
- Basic UDI-DI
- B-04540778150195 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS 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
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
IKAZUCHI Zero 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-04540778150195 | 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 7452ea6f-a5bf-42a3-b2a1-8ada9ca2d996 61 fields · synced Jun 19, 2026