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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 4 of 21

Device	Model / Reference	Registries	Class	Status
IKAZUCHI Zero	ZE-12-400	EUDAMED	Class III	Active
Metacross RX	BD-L60150MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40150MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40020LW	EUDAMED	Class IIa	Active
R2P Crosstella RX	BD-Q30040ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P30080ER	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	352-0820	EUDAMED	Class III	Active
Ed Coil	350-1130R	EUDAMED	Class III	Active
Neon	BS-17530	EUDAMED	Class III	Active
Crosstella RX	BD-F20060MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60150CW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40040LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40080MR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-25008	EUDAMED	Class III	Active
Metacross OTW	BD-L30100MW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-25012	EUDAMED	Class III	Active
Crosstella RX	BD-F25060MR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-18-325	EUDAMED	Class III	Active
Metacross RX	BD-L60100CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F20150LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30200MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60080MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40150MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-01H3	EUDAMED	Class III	Active
Neon Nc	BN-22515	EUDAMED	Class III	Active
R2P Metacross RX	BD-P70100ER	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-30-325	EUDAMED	Class III	Active
Crosperio RX	BD-B40020MR	EUDAMED	Class IIa	Active
Ed Coil	350-0304R	EUDAMED	Class III	Active
Metacross RX	BD-L30200MR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-37530	EUDAMED	Class III	Active
Ed Coil	353-0208	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-12-350	EUDAMED	Class III	Active
Crosstella OTW	BD-F50020MW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-20015	EUDAMED	Class III	Active
Metacross RX	BD-L60020ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70080MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F50040LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B15020MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35200LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F20080LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35200SW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-30013	EUDAMED	Class III	Active
Metacross OTW	BD-L60100SW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-1230R	EUDAMED	Class III	Active
Metacross OTW	BD-L60080CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40060LW	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-18-375	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-8-175	EUDAMED	Class III	Active
Neon Nc	BN-40015	EUDAMED	Class III	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