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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 8 of 21

Device	Model / Reference	Registries	Class	Status
Metacross RX	BD-LX0020CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70040SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20060MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B15040MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25120MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30120ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70120MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30080LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60120SW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S6060MH	EUDAMED	Class IIa	Active
Crosstella RX	BD-F50060MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70100CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40120MR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-25020	EUDAMED	Class III	Active
Senri	BD-S6060L	EUDAMED	Class IIa	Active
IKAZUCHI Zero	ZE-6-200	EUDAMED	Class III	Active
R2P Crosstella RX	BD-Q40020ER	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-01H1RS	EUDAMED	Class III	Active
Metacross RX	BD-L40200CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50060ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25200LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25060LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX0020MR	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S7040LH	EUDAMED	Class IIa	Active
Neon	BS-20015	EUDAMED	Class III	Active
Neon Nc	BN-20020	EUDAMED	Class III	Active
Crosperio RX	BD-B25120LR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P40200ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60100LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25040MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25150MR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-20012	EUDAMED	Class III	Active
Metacross RX	BD-L40080CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60020MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q20150ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40080CW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q30100ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40200MR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-20-350	EUDAMED	Class III	Active
R2P Metacross RX	BD-P70020ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX0040CW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S20150M	EUDAMED	Class IIa	Active
IKAZUCHI Zero	ZE-6-400	EUDAMED	Class III	Active
Ed Coil	350-0720R	EUDAMED	Class III	Active
Crosperio RX	BD-B30200LR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-15-250	EUDAMED	Class III	Active
Neon Nc	BN-40010	EUDAMED	Class III	Active
Crosperio RX	BD-B30080MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30040ER	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