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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 (1028)

Page 1 of 21

Device	Model / Reference	Registries	Class	Status
IKAZUCHI Zero	ZE-18-300	EUDAMED	Class III	Active
Neon	BS-37520	EUDAMED	Class III	Active
Crosperio OTW	BD-B20020MW	EUDAMED	Class IIa	Active
Crosstella RX	BD-F20100LR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-30008	EUDAMED	Class III	Active
Raiden3	RD3-8-250	EUDAMED	Class III	Active
Senri	BD-S2080M	EUDAMED	Class IIa	Active
R2P Crosstella RX	BD-Q40080ER	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-15-225	EUDAMED	Class III	Active
Crosperio OTW	BD-B35200MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20080SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25040MW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-27515	EUDAMED	Class III	Active
Neon Nc	BN-30015	EUDAMED	Class III	Active
Crosperio OTW	BD-B40080SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30080SW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-15-375	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-30-175	EUDAMED	Class III	Active
Crosstella RX	BD-F20040LR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-22520	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-18-275	EUDAMED	Class III	Active
Crosperio OTW	BD-B30020LW	EUDAMED	Class IIa	Active
Crosstella RX	BD-F20150MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20200SW	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-15-325	EUDAMED	Class III	Active
Crosstella RX	BD-F50100LR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q20060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30150MW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S30100M	EUDAMED	Class IIa	Active
R2P Crosstella RX	BD-Q60200ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25040LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40040SW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S5080L	EUDAMED	Class IIa	Active
Crosstella RX	BD-F30060MR	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S7080MH	EUDAMED	Class IIa	Active
Raiden3	RD3-20-450	EUDAMED	Class III	Active
Crosperio RX	BD-B40150LR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q25150ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q60120ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30020SW	EUDAMED	Class IIa	Active
Senri	BD-S20120M	EUDAMED	Class IIa	Active
R2P Crosstella RX	BD-Q25060ER	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-18-200	EUDAMED	Class III	Active
Metacross RX	BD-L90080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20080MW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-22518	EUDAMED	Class III	Active
Crosstella RX	BD-F40020MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX2020CW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-37520	EUDAMED	Class III	Active
Metacross OTW	BD-L70040MW	EUDAMEDFDA UDI	Class IIa	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