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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 19 of 21

Device	Model / Reference	Registries	Class	Status
Ed Coil	353-1610	EUDAMED	Class III	Active
Crosstella RX	BD-F30080MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50040LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60150ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60080LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40020CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60120MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25040SW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-32512	EUDAMED	Class III	Active
Metacross OTW	BD-L50200MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30200CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70200MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-0412R	EUDAMED	Class III	Active
Metacross RX	BD-L30100CR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P30100ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25150LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B40020LR	EUDAMED	Class IIa	Active
Ed Coil	352-1620RS	EUDAMED	Class III	Active
Crosperio RX	BD-B30120LR	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-0312RS	EUDAMED	Class III	Active
Crosperio OTW	BD-B20020LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20040LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60200LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90060ER	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-13-200	EUDAMED	Class III	Active
Neon Nc	BN-32530	EUDAMED	Class III	Active
Crosperio OTW	BD-B25150MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25150MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50020CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20200LW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S5080M	EUDAMED	Class IIa	Active
Metacross OTW	BD-L60060MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50150MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60200CR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-20-400	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-8-300	EUDAMED	Class III	Active
Metacross OTW	BD-L30060CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70080MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70040CR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q50020ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B15040LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30150CW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35080LW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-15010	EUDAMED	Class III	Active
Metacross RX	BD-L40120CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30060MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25150LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60150CR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B15120SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30120SW	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