Senri

EUDAMED

Class IIa (EU MDR)

Ref BD-S7080LHRef BD-S6040LRef BD-S50150MRef BD-S60150MHRef BD-S8060MRef BD-S2060MRef BD-S20100MRef BD-S3040LRef BD-S6080LHRef BD-S3060LRef BD-S6060MRef BD-S7040MRef BD-S4080MRef BD-S5060LRef BD-S50100LRef BD-S8040MHRef BD-S30150MRef BD-S20120LRef BD-S7060LHRef BD-S3080LRef BD-S40100LRef BD-S40120MRef BD-S8040LRef BD-S60120LHRef BD-S40150LRef BD-S50120MRef BD-S50120LRef BD-S7080MRef BD-S3060MRef BD-S2080LRef BD-S6080MRef BD-S2060LRef BD-S6060LHRef BD-S8060MHRef BD-S30120LRef BD-S40150MRef BD-S6080MHRef BD-S2040LRef BD-S8060LHRef BD-S6040MRef BD-S30150LRef BD-S40100MRef BD-S20100LRef BD-S7040MH

by KANEKA Corporation

Identity

Trade Name: Senri EUDAMED
Device Name: Senri EUDAMED
Model / Reference: BD-S7080LH EUDAMED
BD-S6040L EUDAMED
BD-S50150M EUDAMED
BD-S60150MH EUDAMED
BD-S8060M EUDAMED
BD-S2060M EUDAMED
BD-S20100M EUDAMED
BD-S3040L EUDAMED
BD-S6080LH EUDAMED
BD-S3060L EUDAMED
BD-S6060M EUDAMED
BD-S7040M EUDAMED
BD-S4080M EUDAMED
BD-S5060L EUDAMED
BD-S50100L EUDAMED
BD-S8040MH EUDAMED
BD-S30150M EUDAMED
BD-S20120L EUDAMED
BD-S7060LH EUDAMED
BD-S3080L EUDAMED
BD-S40100L EUDAMED
BD-S40120M EUDAMED
BD-S8040L EUDAMED
BD-S60120LH EUDAMED
BD-S40150L EUDAMED
BD-S50120M EUDAMED
BD-S50120L EUDAMED
BD-S7080M EUDAMED
BD-S3060M EUDAMED
BD-S2080L EUDAMED
BD-S6080M EUDAMED
BD-S2060L EUDAMED
BD-S6060LH EUDAMED
BD-S8060MH EUDAMED
BD-S30120L EUDAMED
BD-S40150M EUDAMED
BD-S6080MH EUDAMED
BD-S2040L EUDAMED
BD-S8060LH EUDAMED
BD-S6040M EUDAMED
BD-S30150L EUDAMED
BD-S40100M EUDAMED
BD-S20100L EUDAMED
BD-S7040MH EUDAMED

Identifiers

Primary DI / UDI-DI: 04540778138704 EUDAMED
04540778134560 EUDAMED
04540778138384 EUDAMED
04540778138483 EUDAMED
04540778134478 EUDAMED
04540778138254 EUDAMED
04540778138278 EUDAMED
04540778134539 EUDAMED
04540778138698 EUDAMED
04540778134591 EUDAMED
04540778134454 EUDAMED
04540778134409 EUDAMED
04540778134492 EUDAMED
04540778134614 EUDAMED
04540778138551 EUDAMED
04540778138407 EUDAMED
04540778138360 EUDAMED
04540778138568 EUDAMED
04540778138674 EUDAMED
04540778134652 EUDAMED
04540778138544 EUDAMED
04540778138339 EUDAMED
04540778134584 EUDAMED
04540778138728 EUDAMED
04540778138629 EUDAMED
04540778138346 EUDAMED
04540778138599 EUDAMED
04540778134522 EUDAMED
04540778134423 EUDAMED
04540778138513 EUDAMED
04540778134515 EUDAMED
04540778138506 EUDAMED
04540778138667 EUDAMED
04540778138438 EUDAMED
04540778138575 EUDAMED
04540778138377 EUDAMED
04540778138445 EUDAMED
04540778138490 EUDAMED
04540778138681 EUDAMED
04540778134393 EUDAMED
04540778138612 EUDAMED
04540778138292 EUDAMED
04540778138520 EUDAMED
04540778138391 EUDAMED
Basic UDI-DI: B-04540778138704 EUDAMED
B-04540778134560 EUDAMED
B-04540778138384 EUDAMED
B-04540778138483 EUDAMED
B-04540778134478 EUDAMED
B-04540778138254 EUDAMED
B-04540778138278 EUDAMED
B-04540778134539 EUDAMED
B-04540778138698 EUDAMED
B-04540778134591 EUDAMED
B-04540778134454 EUDAMED
B-04540778134409 EUDAMED
B-04540778134492 EUDAMED
B-04540778134614 EUDAMED
B-04540778138551 EUDAMED
B-04540778138407 EUDAMED
B-04540778138360 EUDAMED
B-04540778138568 EUDAMED
B-04540778138674 EUDAMED
B-04540778134652 EUDAMED
B-04540778138544 EUDAMED
B-04540778138339 EUDAMED
B-04540778134584 EUDAMED
B-04540778138728 EUDAMED
B-04540778138629 EUDAMED
B-04540778138346 EUDAMED
B-04540778138599 EUDAMED
B-04540778134522 EUDAMED
B-04540778134423 EUDAMED
B-04540778138513 EUDAMED
B-04540778134515 EUDAMED
B-04540778138506 EUDAMED
B-04540778138667 EUDAMED
B-04540778138438 EUDAMED
B-04540778138575 EUDAMED
B-04540778138377 EUDAMED
B-04540778138445 EUDAMED
B-04540778138490 EUDAMED
B-04540778138681 EUDAMED
B-04540778134393 EUDAMED
B-04540778138612 EUDAMED
B-04540778138292 EUDAMED
B-04540778138520 EUDAMED
B-04540778138391 EUDAMED
EMDN Code: C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Peripheral angioplasty balloon catheter, basic

Senri by KANEKA Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

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ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
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Armada — Abbott Vascular · Class II
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Chocolate PTA Balloon Catheter — TRIREME MEDICAL, LLC · Class II

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-04540778138704	Class IIa	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 (44)

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EUDAMED 6dad9d6a-d559-4ff3-afdf-e38563aab4d2 61 fields · synced May 16, 2026
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EUDAMED 80c78e10-5297-4c98-bd50-ec8a063600ba 61 fields · synced May 16, 2026
EUDAMED 6f027c18-fa5e-4c96-b041-c8f98289df8c 61 fields · synced May 16, 2026
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EUDAMED f4268e7f-89a4-460b-b584-4df573a100ed 61 fields · synced May 16, 2026
EUDAMED ae9bc3b3-a76d-42eb-a620-7c451d2058e7 61 fields · synced May 16, 2026
EUDAMED 845ab176-4856-423c-b220-f012fd018a40 61 fields · synced May 17, 2026
EUDAMED 2dac5ddc-2ecd-4bec-b47a-bd4f3bbe20f8 61 fields · synced May 17, 2026
EUDAMED c47895d3-fda0-456a-84bb-3ade8ce8fae2 61 fields · synced May 17, 2026
EUDAMED cc7d8077-d52f-4f5f-bfe5-5bbbe978ce4b 61 fields · synced May 17, 2026
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EUDAMED b2d6d13d-6b51-4869-88aa-02fabf74be95 61 fields · synced May 17, 2026
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EUDAMED 9850c298-1b94-405e-9d4e-f686ce09f752 61 fields · synced May 17, 2026
EUDAMED ccc00e78-3e5d-478e-aebd-5457cc393ea7 61 fields · synced May 17, 2026
EUDAMED 7cbe8193-17f1-411e-8071-aae53a7e28b3 61 fields · synced May 17, 2026
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EUDAMED eb24c012-2d99-402a-9832-346df552fceb 61 fields · synced May 17, 2026
EUDAMED 5834ed1b-e657-408d-96bf-74c6bae453ef 61 fields · synced May 17, 2026
EUDAMED 0d3b176e-1c50-4093-8d50-65c31eab1504 61 fields · synced May 17, 2026
EUDAMED d89f4af8-9eb4-4f75-ac7b-4b1f57d4b196 61 fields · synced May 17, 2026
EUDAMED dd7d232b-a9f8-4118-9a04-1b49150b2c20 61 fields · synced May 17, 2026
EUDAMED 7938f29f-620f-41a3-ac83-ebcff914cb8e 61 fields · synced May 17, 2026
EUDAMED deb80738-6d8d-4446-82c2-8c0766ef72d5 61 fields · synced May 18, 2026
EUDAMED 69d35da7-3191-4e58-866f-98a8bd268af4 61 fields · synced May 18, 2026
EUDAMED 124f96ab-d835-41ab-9ae9-2b927b5dc465 61 fields · synced May 18, 2026
EUDAMED d9af8a43-c3d8-4d18-bcbf-52cc0695b756 61 fields · synced May 18, 2026
EUDAMED eb14edc1-2211-4789-9bc7-627126ea38f7 61 fields · synced May 18, 2026
EUDAMED 993c2215-196b-4624-b661-2c997802239e 61 fields · synced May 18, 2026
EUDAMED 90efb00c-9d5a-447b-bf4e-a08accee8ee3 61 fields · synced May 18, 2026
EUDAMED df14509f-2a20-47df-abf1-4bb4ec39a362 61 fields · synced May 18, 2026
EUDAMED f845f528-8f8b-4d25-9fde-acf783b5a471 61 fields · synced May 18, 2026
EUDAMED c685196b-b4cd-4287-ad1f-8dcbe0bba818 61 fields · synced May 18, 2026
EUDAMED 9aae5379-8d6a-43ca-bcd2-d9c03279b363 61 fields · synced May 18, 2026
EUDAMED c5112952-e64e-4212-9395-15bf8d7f78e4 61 fields · synced May 18, 2026
EUDAMED ebc1d3da-5955-4a82-800a-436782b62a43 61 fields · synced May 19, 2026
EUDAMED c1146471-4730-44bd-813f-b3fdf22a3261 61 fields · synced May 19, 2026
EUDAMED 919b0b82-3b89-4987-98b1-314e4d6d7efc 61 fields · synced May 19, 2026
EUDAMED 2c92924f-78c8-4b5c-8f89-6a000e01b4df 61 fields · synced May 19, 2026