← Back to catalogue
Raiden3
EUDAMEDClass III (EU MDR)
Ref RD3-8-450Model Kaneka PTCA Balloon Dilatation CathetersRef RD3-10-250Ref RD3-8-425Ref RD3-30-375Ref RD3-15-350Ref RD3-13-275Ref RD3-8-350Ref RD3-30-225Ref RD3-13-350Ref RD3-18-325Ref RD3-10-400Ref RD3-20-275Ref RD3-13-425Ref RD3-13-400Ref RD3-8-325Ref RD3-15-225Ref RD3-30-300Ref RD3-10-425Ref RD3-8-275Ref RD3-10-325Ref RD3-15-300Ref RD3-20-225Ref RD3-30-450Ref RD3-18-250Ref RD3-20-250Ref RD3-13-375Ref RD3-15-425Ref RD3-18-350Ref RD3-15-400Ref RD3-10-375Ref RD3-10-275Ref RD3-8-175Ref RD3-30-275Ref RD3-10-225Ref RD3-15-450Ref RD3-20-425Ref RD3-18-425Ref RD3-20-300Ref RD3-30-250Ref RD3-13-300Ref RD3-8-300Ref RD3-10-300Ref RD3-10-200Ref RD3-18-450Ref RD3-8-150Ref RD3-13-450Ref RD3-8-375Ref RD3-8-200Ref RD3-18-225
Identity
- Trade Name
- Raiden3 EUDAMED
- Device Name
- Raiden3 EUDAMED
- Model / Reference
- Kaneka PTCA Balloon Dilatation Catheters EUDAMEDRD3-8-450 EUDAMEDRD3-10-250 EUDAMEDRD3-8-425 EUDAMEDRD3-30-375 EUDAMEDRD3-15-350 EUDAMEDRD3-13-275 EUDAMEDRD3-8-350 EUDAMEDRD3-30-225 EUDAMEDRD3-13-350 EUDAMEDRD3-18-325 EUDAMEDRD3-10-400 EUDAMEDRD3-20-275 EUDAMEDRD3-13-425 EUDAMEDRD3-13-400 EUDAMEDRD3-8-325 EUDAMEDRD3-15-225 EUDAMEDRD3-30-300 EUDAMEDRD3-10-425 EUDAMEDRD3-8-275 EUDAMEDRD3-10-325 EUDAMEDRD3-15-300 EUDAMEDRD3-20-225 EUDAMEDRD3-30-450 EUDAMEDRD3-18-250 EUDAMEDRD3-20-250 EUDAMEDRD3-13-375 EUDAMEDRD3-15-425 EUDAMEDRD3-18-350 EUDAMEDRD3-15-400 EUDAMEDRD3-10-375 EUDAMEDRD3-10-275 EUDAMEDRD3-8-175 EUDAMEDRD3-30-275 EUDAMEDRD3-10-225 EUDAMEDRD3-15-450 EUDAMEDRD3-20-425 EUDAMEDRD3-18-425 EUDAMEDRD3-20-300 EUDAMEDRD3-30-250 EUDAMEDRD3-13-300 EUDAMEDRD3-8-300 EUDAMEDRD3-10-300 EUDAMEDRD3-10-200 EUDAMEDRD3-18-450 EUDAMEDRD3-8-150 EUDAMEDRD3-13-450 EUDAMEDRD3-8-375 EUDAMEDRD3-8-200 EUDAMEDRD3-18-225 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778149434 EUDAMED04540778145016 EUDAMED04540778149427 EUDAMED04540778149755 EUDAMED04540778145146 EUDAMED04540778149472 EUDAMED04540778149397 EUDAMED04540778149694 EUDAMED04540778149502 EUDAMED04540778149601 EUDAMED04540778145078 EUDAMED04540778145207 EUDAMED04540778149533 EUDAMED04540778149526 EUDAMED04540778149380 EUDAMED04540778145092 EUDAMED04540778149724 EUDAMED04540778146570 EUDAMED04540778149366 EUDAMED04540778145047 EUDAMED04540778145122 EUDAMED04540778149670 EUDAMED04540778149786 EUDAMED04540778149571 EUDAMED04540778145191 EUDAMED04540778149519 EUDAMED04540778145177 EUDAMED04540778149618 EUDAMED04540778145160 EUDAMED04540778145061 EUDAMED04540778145023 EUDAMED04540778144989 EUDAMED04540778149717 EUDAMED04540778145009 EUDAMED04540778145184 EUDAMED04540778145269 EUDAMED04540778149649 EUDAMED04540778145214 EUDAMED04540778149700 EUDAMED04540778149489 EUDAMED04540778149373 EUDAMED04540778145030 EUDAMED04540778144996 EUDAMED04540778149656 EUDAMED04540778144972 EUDAMED04540778149540 EUDAMED04540778149403 EUDAMED04540778149335 EUDAMED04540778149564 EUDAMED
- Basic UDI-DI
- B-04540778149434 EUDAMEDB-04540778145016 EUDAMEDB-04540778149427 EUDAMEDB-04540778149755 EUDAMEDB-04540778145146 EUDAMEDB-04540778149472 EUDAMEDB-04540778149397 EUDAMEDB-04540778149694 EUDAMEDB-04540778149502 EUDAMEDB-04540778149601 EUDAMEDB-04540778145078 EUDAMEDB-04540778145207 EUDAMEDB-04540778149533 EUDAMEDB-04540778149526 EUDAMEDB-04540778149380 EUDAMEDB-04540778145092 EUDAMEDB-04540778149724 EUDAMEDB-04540778146570 EUDAMEDB-04540778149366 EUDAMEDB-04540778145047 EUDAMEDB-04540778145122 EUDAMEDB-04540778149670 EUDAMEDB-04540778149786 EUDAMEDB-04540778149571 EUDAMEDB-04540778145191 EUDAMEDB-04540778149519 EUDAMEDB-04540778145177 EUDAMEDB-04540778149618 EUDAMEDB-04540778145160 EUDAMEDB-04540778145061 EUDAMEDB-04540778145023 EUDAMEDB-04540778144989 EUDAMEDB-04540778149717 EUDAMEDB-04540778145009 EUDAMEDB-04540778145184 EUDAMEDB-04540778145269 EUDAMEDB-04540778149649 EUDAMEDB-04540778145214 EUDAMEDB-04540778149700 EUDAMEDB-04540778149489 EUDAMEDB-04540778149373 EUDAMEDB-04540778145030 EUDAMEDB-04540778144996 EUDAMEDB-04540778149656 EUDAMEDB-04540778144972 EUDAMEDB-04540778149540 EUDAMEDB-04540778149403 EUDAMEDB-04540778149335 EUDAMEDB-04540778149564 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands 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
Raiden3 by KANEKA Corporation — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- Kulani™ NC — Meril Life Sciences Pvt. Ltd. · Class III
- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
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-04540778149434 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (51)
- EUDAMED 32437d85-318d-437a-85e1-08b676c45779 61 fields · synced Sep 18, 2026
- EUDAMED 5e37b8fd-f6b4-45b4-849c-ae0909905d51 61 fields · synced May 11, 2026
- EUDAMED cfbf6932-75ee-406c-9b30-fee4f84bb489 61 fields · synced May 16, 2026
- EUDAMED d6ca8510-d99b-4c33-bc87-86e877c0ddb5 61 fields · synced May 16, 2026
- EUDAMED d3878a94-c51f-451f-b067-9a2ae6ed5cda 61 fields · synced May 16, 2026
- EUDAMED 618a895c-7c5b-4d7c-9710-c69c3fd8b1bf 61 fields · synced May 16, 2026
- EUDAMED 6095ae07-fa13-416d-9061-d2c66a0936e4 61 fields · synced May 16, 2026
- EUDAMED 2481f322-695e-49f6-afec-2ad7ec6dd1ca 61 fields · synced May 16, 2026
- EUDAMED a3dae1ed-2792-46ac-8390-737527f22d74 61 fields · synced May 16, 2026
- EUDAMED 55000401-ab22-473e-9827-f5b30e9a3575 61 fields · synced May 16, 2026
- EUDAMED 5987c899-b327-4837-a77e-4686ff276e35 61 fields · synced May 16, 2026
- EUDAMED 5e45f361-ad8a-48a0-9e4b-3d61adc6d5ca 61 fields · synced May 16, 2026
- EUDAMED ed1da0ae-a3c2-40a1-86b1-e85f370e5786 61 fields · synced May 16, 2026
- EUDAMED c31b37d2-4318-4a2a-ba2f-54550d9de117 61 fields · synced May 16, 2026
- EUDAMED 4e08e828-f0bb-4d56-881b-cb668e6f3e71 61 fields · synced May 17, 2026
- EUDAMED 15bff31a-0f0e-443c-ae2a-0202794033f4 61 fields · synced May 17, 2026
- EUDAMED 36ef059b-bb9a-4471-964b-54869462b4b6 61 fields · synced May 17, 2026
- EUDAMED b894019c-b2e5-4fc2-861c-76408fbee3f5 61 fields · synced May 17, 2026
- EUDAMED 472ae533-3e71-4414-9048-8c97c009e3fb 61 fields · synced May 17, 2026
- EUDAMED 01030c51-2ad5-4e96-a126-f175f7d740a8 61 fields · synced May 17, 2026
- EUDAMED a0345094-78d2-4317-a7a0-763fefb39fe7 61 fields · synced May 17, 2026
- EUDAMED 5220c7ed-b5fb-4e4c-9acf-739bcab052c6 61 fields · synced May 17, 2026
- EUDAMED 89489712-d48f-45ab-badf-b80093c84189 61 fields · synced May 17, 2026
- EUDAMED 24bf5088-b8e3-4301-b824-49bb20b3787c 61 fields · synced May 17, 2026
- EUDAMED fad1b653-886e-4335-a85c-c9f339c7dd6d 61 fields · synced May 17, 2026
- EUDAMED 095deb52-884c-4dfc-bc82-7d446a72dd1f 61 fields · synced May 17, 2026
- EUDAMED 94fab765-a3fb-48d9-a37f-9623ba882a4f 61 fields · synced May 17, 2026
- EUDAMED 8d259538-593f-4618-8ecd-d88947ec5597 61 fields · synced May 17, 2026
- EUDAMED 5657cbca-0b1a-4baf-8b63-baf2cbe3f165 61 fields · synced May 17, 2026
- EUDAMED 5923ac52-4380-48d3-a33e-74955f8011f5 61 fields · synced May 17, 2026
- EUDAMED d977509f-2f7c-4869-98ff-78d996b0f7a8 61 fields · synced May 17, 2026
- EUDAMED ff419444-02f9-4bff-af46-2c865c25758f 61 fields · synced May 17, 2026
- EUDAMED a0c6b87c-d48d-4d0f-9514-b63814979d61 61 fields · synced May 18, 2026
- EUDAMED 00f9761b-ea7c-493d-a422-783c4ac2f00f 61 fields · synced May 18, 2026
- EUDAMED 77b51144-ada3-4ba9-83de-2fbbe709490f 61 fields · synced May 18, 2026
- EUDAMED 60077290-e21d-4e12-878b-5778ac20783c 61 fields · synced May 18, 2026
- EUDAMED dd541a47-cfef-452c-83b2-09894b8ca082 61 fields · synced May 18, 2026
- EUDAMED 3766e4ce-eed5-45c8-919b-26d3bcd7e746 61 fields · synced May 18, 2026
- EUDAMED ada9b6de-6e3a-4ee6-8e15-2985b3b7acf2 61 fields · synced May 18, 2026
- EUDAMED 236a0382-af75-46c4-9623-a575f5db6217 61 fields · synced May 18, 2026
- EUDAMED e16e16cc-9fdf-4802-9b7d-157d3961f27e 61 fields · synced May 18, 2026
- EUDAMED cecd4159-18b7-43e0-a40c-f4c1d07bd6de 61 fields · synced May 18, 2026
- EUDAMED f3eac8d7-a7aa-4c9b-a39a-acdc055a35f8 61 fields · synced May 18, 2026
- EUDAMED b0553ebf-fd94-41db-8669-9bd3d696f8f2 61 fields · synced May 18, 2026
- EUDAMED 18752b76-646b-4a04-8c0d-fe2c448c7d75 61 fields · synced May 18, 2026
- EUDAMED 1355a477-d034-48bc-ae75-df22e999fd84 61 fields · synced May 18, 2026
- EUDAMED 5ed73070-b98f-4a40-ba18-301ac46d3a2b 61 fields · synced May 19, 2026
- EUDAMED 9e23a32e-f3fe-4e86-9d0e-92671d13be96 61 fields · synced May 19, 2026
- EUDAMED 87ff1d9e-49e7-43eb-ac38-344cb61ace62 61 fields · synced May 19, 2026
- EUDAMED cafd63d5-a668-409d-b31d-c0b030454b97 61 fields · synced Aug 1, 2026
- EUDAMED 53f16905-23bd-4465-9392-03d947c01665 61 fields · synced Aug 1, 2026