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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 10 of 21

Device	Model / Reference	Registries	Class	Status
Senri	BD-S3080M	EUDAMED	Class IIa	Active
Metacross RX	BD-L80060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX0040MR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-25018	EUDAMED	Class III	Active
Crosstella RX	BD-F40150MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20150MW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-37518	EUDAMED	Class III	Active
Metacross OTW	BD-L30200MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F30040LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35020LR	EUDAMED	Class IIa	Active
Metacross RX	BD-L50020MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F50150LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B15040LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50040SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70200SW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S7040L	EUDAMED	Class IIa	Active
R2P Crosstella RX	BD-Q25200ER	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S30120M	EUDAMED	Class IIa	Active
Crosperio OTW	BD-B20120SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40100LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40080MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80060SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50100CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50150LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40150LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40040CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60060LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40150SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25080MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30100ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35200MR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-20-375	EUDAMED	Class III	Active
Crosperio RX	BD-B20080LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60080LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30150MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90060MR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-12-225	EUDAMED	Class III	Active
Metacross RX	BD-L40080ER	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S30100L	EUDAMED	Class IIa	Active
R2P Metacross RX	BD-P40150ER	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-0820RS	EUDAMED	Class III	Active
Senri	BD-S4060L	EUDAMED	Class IIa	Active
Raiden3	RD3-13-325	EUDAMED	Class III	Active
Ed Coil	350-0830RS	EUDAMED	Class III	Active
Metacross RX	BD-L70060MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L80080CR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P70060ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40020SW	EUDAMED	Class IIa	Active
Metacross OTW	BD-L50120SW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q50150ER	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