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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 7 of 21

Device	Model / Reference	Registries	Class	Status
IKAZUCHI Zero	ZE-30-150	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-20-250	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-15-300	EUDAMED	Class III	Active
Metacross RX	BD-LX0060CR	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-01H2R	EUDAMED	Class III	Active
Senri	BD-S40120L	EUDAMED	Class IIa	Active
R2P Crosstella RX	BD-Q60080ER	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-20-275	EUDAMED	Class III	Active
Crosstella OTW	BD-F25020LW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-22512	EUDAMED	Class III	Active
Metacross OTW	BD-L70020SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25200LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX0080CW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25080MW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-15020	EUDAMED	Class III	Active
R2P Metacross RX	BD-P60200ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B30020LR	EUDAMED	Class IIa	Active
Metacross RX	BD-L80060MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60080MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P50080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25020MR	EUDAMED	Class IIa	Active
Crosstella RX	BD-F20080MR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-37506	EUDAMED	Class III	Active
Metacross RX	BD-L40150CR	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-1230RS	EUDAMED	Class III	Active
Senri	BD-S50100M	EUDAMED	Class IIa	Active
IKAZUCHI Zero	ZE-20-225	EUDAMED	Class III	Active
R2P Metacross RX	BD-P60060ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20060LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90020CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50080MW	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-18-300	EUDAMED	Class III	Active
Ed Coil	353-0208R	EUDAMED	Class III	Active
Neon	BS-25006	EUDAMED	Class III	Active
Ed Coil	350-0209R	EUDAMED	Class III	Active
Neon	BS-25020	EUDAMED	Class III	Active
Crosstella RX	BD-F25120LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX0020CW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q20120ER	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-30-375	EUDAMED	Class III	Active
Senri	BD-S4080L	EUDAMED	Class IIa	Active
Raiden3	RD3-30-350	EUDAMED	Class III	Active
Neon	BS-10008F	EUDAMED	Class III	Active
Crosstella RX	BD-F60100MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B15040MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX2020MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20080LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60100MR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-6-350	EUDAMED	Class III	Active
Crosperio OTW	BD-B35080MW	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