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IKAZUCHI Zero
EUDAMEDClass III (EU MDR)
Ref ZE-6-300Model Kaneka PTCA Balloon Dilatation CathetersRef ZE-6-325Ref ZE-30-250Ref ZE-10-300Ref ZE-20-400Ref ZE-6-250Ref ZE-18-375Ref ZE-12-300Ref ZE-30-400Ref ZE-6-100PRef ZE-10-175Ref ZE-18-225Ref ZE-30-325Ref ZE-18-175Ref ZE-12-175Ref ZE-8-350Ref ZE-10-350Ref ZE-6-375Ref ZE-15-325Ref ZE-6-175Ref ZE-8-400Ref ZE-18-150Ref ZE-15-175Ref ZE-10-250Ref ZE-12-375Ref ZE-8-375Ref ZE-12-325Ref ZE-20-350Ref ZE-20-300Ref ZE-10-375Ref ZE-18-400Ref ZE-12-150Ref ZE-8-225Ref ZE-8-100FRef ZE-18-250Ref ZE-8-325Ref ZE-8-100PRef ZE-15-350Ref ZE-15-200Ref ZE-10-325Ref ZE-15-275Ref ZE-30-350Ref ZE-8-120Ref ZE-10-200Ref ZE-20-175
Identity
- Trade Name
- IKAZUCHI Zero EUDAMED
- Device Name
- IKAZUCHI Zero EUDAMED
- Model / Reference
- Kaneka PTCA Balloon Dilatation Catheters EUDAMEDZE-6-300 EUDAMEDZE-6-325 EUDAMEDZE-30-250 EUDAMEDZE-10-300 EUDAMEDZE-20-400 EUDAMEDZE-6-250 EUDAMEDZE-18-375 EUDAMEDZE-12-300 EUDAMEDZE-30-400 EUDAMEDZE-6-100P EUDAMEDZE-10-175 EUDAMEDZE-18-225 EUDAMEDZE-30-325 EUDAMEDZE-18-175 EUDAMEDZE-12-175 EUDAMEDZE-8-350 EUDAMEDZE-10-350 EUDAMEDZE-6-375 EUDAMEDZE-15-325 EUDAMEDZE-6-175 EUDAMEDZE-8-400 EUDAMEDZE-18-150 EUDAMEDZE-15-175 EUDAMEDZE-10-250 EUDAMEDZE-12-375 EUDAMEDZE-8-375 EUDAMEDZE-12-325 EUDAMEDZE-20-350 EUDAMEDZE-20-300 EUDAMEDZE-10-375 EUDAMEDZE-18-400 EUDAMEDZE-12-150 EUDAMEDZE-8-225 EUDAMEDZE-8-100F EUDAMEDZE-18-250 EUDAMEDZE-8-325 EUDAMEDZE-8-100P EUDAMEDZE-15-350 EUDAMEDZE-15-200 EUDAMEDZE-10-325 EUDAMEDZE-15-275 EUDAMEDZE-30-350 EUDAMEDZE-8-120 EUDAMEDZE-10-200 EUDAMEDZE-20-175 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778149861 EUDAMED04540778149878 EUDAMED04540778150379 EUDAMED04540778146051 EUDAMED04540778146266 EUDAMED04540778149847 EUDAMED04540778150294 EUDAMED04540778150133 EUDAMED04540778150430 EUDAMED04540778145993 EUDAMED04540778150058 EUDAMED04540778150232 EUDAMED04540778150409 EUDAMED04540778150218 EUDAMED04540778150089 EUDAMED04540778150027 EUDAMED04540778146075 EUDAMED04540778149892 EUDAMED04540778146150 EUDAMED04540778149816 EUDAMED04540778150041 EUDAMED04540778150201 EUDAMED04540778150188 EUDAMED04540778146037 EUDAMED04540778150164 EUDAMED04540778150034 EUDAMED04540778150140 EUDAMED04540778146259 EUDAMED04540778146235 EUDAMED04540778150065 EUDAMED04540778150300 EUDAMED04540778150072 EUDAMED04540778149977 EUDAMED04540778149915 EUDAMED04540778150249 EUDAMED04540778150010 EUDAMED04540778149922 EUDAMED04540778146167 EUDAMED04540778146105 EUDAMED04540778146068 EUDAMED04540778146136 EUDAMED04540778150416 EUDAMED04540778149939 EUDAMED04540778146013 EUDAMED04540778150317 EUDAMED
- Basic UDI-DI
- B-04540778149861 EUDAMEDB-04540778149878 EUDAMEDB-04540778150379 EUDAMEDB-04540778146051 EUDAMEDB-04540778146266 EUDAMEDB-04540778149847 EUDAMEDB-04540778150294 EUDAMEDB-04540778150133 EUDAMEDB-04540778150430 EUDAMEDB-04540778145993 EUDAMEDB-04540778150058 EUDAMEDB-04540778150232 EUDAMEDB-04540778150409 EUDAMEDB-04540778150218 EUDAMEDB-04540778150089 EUDAMEDB-04540778150027 EUDAMEDB-04540778146075 EUDAMEDB-04540778149892 EUDAMEDB-04540778146150 EUDAMEDB-04540778149816 EUDAMEDB-04540778150041 EUDAMEDB-04540778150201 EUDAMEDB-04540778150188 EUDAMEDB-04540778146037 EUDAMEDB-04540778150164 EUDAMEDB-04540778150034 EUDAMEDB-04540778150140 EUDAMEDB-04540778146259 EUDAMEDB-04540778146235 EUDAMEDB-04540778150065 EUDAMEDB-04540778150300 EUDAMEDB-04540778150072 EUDAMEDB-04540778149977 EUDAMEDB-04540778149915 EUDAMEDB-04540778150249 EUDAMEDB-04540778150010 EUDAMEDB-04540778149922 EUDAMEDB-04540778146167 EUDAMEDB-04540778146105 EUDAMEDB-04540778146068 EUDAMEDB-04540778146136 EUDAMEDB-04540778150416 EUDAMEDB-04540778149939 EUDAMEDB-04540778146013 EUDAMEDB-04540778150317 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
Category: Coronary angioplasty balloon catheter, cutting/scoring
IKAZUCHI Zero by KANEKA Corporation — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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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-04540778149861 | 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 (45)
- EUDAMED 229da897-674c-4a2f-be6b-69207ebe499d 61 fields · synced Sep 17, 2026
- EUDAMED 4aac4423-2e3f-422d-9549-f3fc3e243b55 61 fields · synced May 11, 2026
- EUDAMED a9bbe802-6e7b-4dc1-84d9-412135b16f45 61 fields · synced May 11, 2026
- EUDAMED 05853b7f-a574-40fb-b9d4-a6f5a81d145d 61 fields · synced May 11, 2026
- EUDAMED 23f58e9e-4fe9-4083-ac7a-671a745884bd 61 fields · synced May 16, 2026
- EUDAMED e2655833-e1e3-4a25-aa46-a2c9c659cccd 61 fields · synced May 16, 2026
- EUDAMED 8faa3d5a-1645-4df3-847d-6f8671b5b773 61 fields · synced May 16, 2026
- EUDAMED d017ad97-f134-482a-949c-e7fc627269f7 61 fields · synced May 16, 2026
- EUDAMED a9f45c0d-99ff-4d98-9741-e089e38ad4b7 61 fields · synced May 16, 2026
- EUDAMED 1fc61e98-e3a6-4b08-b650-82d42c731f34 61 fields · synced May 16, 2026
- EUDAMED 9c3c8375-10fb-411b-9d63-cee398858b77 61 fields · synced May 16, 2026
- EUDAMED 0d46da66-ea4a-421e-82a4-267947e65a41 61 fields · synced May 16, 2026
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- EUDAMED f5659369-cd50-4d31-8cc2-989fdc1fe1c7 61 fields · synced May 16, 2026
- EUDAMED a6aab783-f72f-4d41-ba5a-678d5d32aaa3 61 fields · synced May 17, 2026
- EUDAMED 841d0f94-0150-405a-9f18-d24eca6b4ae5 61 fields · synced May 17, 2026
- EUDAMED 45a9d83c-6df8-4c8d-90d6-366529c77ade 61 fields · synced May 17, 2026
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- EUDAMED 1d2c2768-7156-483f-a9a6-102035c3b793 61 fields · synced May 17, 2026
- EUDAMED 2fce2973-2e48-49a3-9c46-f8c015b1e83a 61 fields · synced May 17, 2026
- EUDAMED b58aebf3-ba9f-4543-b229-708c8d5f377e 61 fields · synced May 17, 2026
- EUDAMED 62af2ff4-c473-4585-8f7f-5bbc76cbda1b 61 fields · synced May 17, 2026
- EUDAMED 35909a44-90a9-4fb1-9eee-5a43f5f6c9bf 61 fields · synced May 18, 2026
- EUDAMED 53c4a0ed-d8ea-4708-b63c-593b1d2be609 61 fields · synced May 18, 2026
- EUDAMED 95332d77-f5f9-49fe-bea6-2dcba721ad1a 61 fields · synced May 18, 2026
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- EUDAMED 6a75f8ba-92df-44b1-8a22-ab22b70c1a12 61 fields · synced May 18, 2026
- EUDAMED f2bd2303-3f08-4e94-9ee0-53fbd118e72e 61 fields · synced May 18, 2026
- EUDAMED 7b72db21-06cb-4d40-9b92-9d46c33d04bf 61 fields · synced May 18, 2026
- EUDAMED 22a2f1f8-275c-41b6-8d9b-a00c5f12b80e 61 fields · synced May 18, 2026
- EUDAMED 04819df9-b071-4bc8-92d7-291ce667fae9 61 fields · synced May 18, 2026
- EUDAMED a804e963-b890-4815-ad15-f754b51e1802 61 fields · synced May 18, 2026
- EUDAMED 9bd34d46-2160-4b72-bfcf-f3478bd262f1 61 fields · synced May 18, 2026
- EUDAMED 8d1cdb47-591f-4cd3-bb68-5f5a7e579e6d 61 fields · synced May 19, 2026
- EUDAMED 78cc820f-094b-4949-91e4-ab5ba246c1d1 61 fields · synced May 19, 2026
- EUDAMED 743c9a19-cb7d-47e0-9f8a-e71b0ee1b95a 61 fields · synced May 19, 2026
- EUDAMED 26ff3367-cc1a-4ca6-9180-7a38837894dd 61 fields · synced May 19, 2026
- EUDAMED 1cf5b4b8-de01-4330-83b5-c7ac5dc194ed 61 fields · synced May 19, 2026
- EUDAMED 3a977080-15b4-4f09-ae66-767a76847982 61 fields · synced May 19, 2026
- EUDAMED 22463211-ba8d-42d1-8606-3a50260356fc 61 fields · synced May 19, 2026
- EUDAMED 81be044f-53eb-4d8d-af0a-cb40d88faecb 61 fields · synced May 19, 2026
- EUDAMED 6cdc13c0-dede-4f99-966b-873c8130ddfd 61 fields · synced May 19, 2026