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KANEKA Corporation

Japan·JP-MF-000022143

Last updated May 25, 2026

Information

Country: Japan
Address: 3-18, 2-chome Nakanoshima, Osaka-city, Japan
Website: www.kaneka.co.jp/en/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +815031339235
PRRC Contact: Kazuaki Sanaka
EUDAMED SRN: JP-MF-000022143
FDA FEI Number: —
DUNS Number: 690535406

Catalogue (1026)

Page 2 of 21

Device	Model / Reference	Registries	Class	Status
Senri	BD-S6080L	EUDAMED	Class IIa	Active
Crosstella RX	BD-F25020MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40020MW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-22530	EUDAMED	Class III	Active
Neon Nc	BN-42515	EUDAMED	Class III	Active
Crosstella RX	BD-F30120LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80060MW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S60150LH	EUDAMED	Class IIa	Active
Neon	BS-10008	EUDAMED	Class III	Active
R2P Crosstella RX	BD-Q50100ER	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-27508	EUDAMED	Class III	Active
Crosstella OTW	BD-F50120MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35120MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40100MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q40100ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q25020ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q40150ER	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-20-200	EUDAMED	Class III	Active
Crosperio OTW	BD-B30200LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35150LW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q25080ER	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-25015	EUDAMED	Class III	Active
Crosstella OTW	BD-F60150LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40200ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q50080ER	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S8040LH	EUDAMED	Class IIa	Active
Raiden3	RD3-18-275	EUDAMED	Class III	Active
Crosperio OTW	BD-B40200LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20040LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25020SW	EUDAMED	Class IIa	Active
Neon Nc	BN-32515	EUDAMED	Class III	Active
Crosperio OTW	BD-B25120LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30200CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20120LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40120MW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S60120MH	EUDAMED	Class IIa	Active
Crosstella RX	BD-F20100MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q20080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B30150MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25080LR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-40018	EUDAMED	Class III	Active
Crosstella RX	BD-F20020MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25060LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25200LR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-35018	EUDAMED	Class III	Active
Crosstella RX	BD-F60150MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B15040SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25150SW	EUDAMEDFDA UDI	Class IIa	Active
OTW Takeru PTCA Balloon Dilatation Catheter	K172264	FDA 510(k)	Class II	Active
RX Takeru Balloon Dilatation Catheter	K163372	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Kaneka Medical Europe N.V. BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Kaneka Corp. US