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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 5 of 21

Device	Model / Reference	Registries	Class	Status
Metacross RX	BD-L90080MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F30020MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50020CW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q20200ER	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-37530	EUDAMED	Class III	Active
Senri	BD-S7060MH	EUDAMED	Class IIa	Active
Crosstella OTW	BD-F20100MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60150LR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q20100ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40200LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90080SW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q40200ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P50060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80020MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20120MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40100MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80040CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25150MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30150CR	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S5040M	EUDAMED	Class IIa	Active
Crosperio RX	BD-B15080LR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-17512	EUDAMED	Class III	Active
Crosstella RX	BD-F30100MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30040LW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-8-250	EUDAMED	Class III	Active
Metacross RX	BD-LX0020ER	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-32518	EUDAMED	Class III	Active
Crosstella RX	BD-F50100MR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-25010	EUDAMED	Class III	Active
Crosstella OTW	BD-F50080LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX2040MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-02H3RS	EUDAMED	Class III	Active
Crosperio OTW	BD-B15080LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20120MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50150ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60120MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-0202RS	EUDAMED	Class III	Active
Raiden3	RD3-8-225	EUDAMED	Class III	Active
Ed Coil	350-0206R	EUDAMED	Class III	Active
Crosperio OTW	BD-B25120SW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-22513	EUDAMED	Class III	Active
Crosperio RX	BD-B35120LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40040SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40120MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90040MR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-17508	EUDAMED	Class III	Active
Crosstella RX	BD-F30200LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80080MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F50020LR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-15-275	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