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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 17 of 21

Device	Model / Reference	Registries	Class	Status
Crosstella OTW	BD-F40040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60040CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40200MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60200LW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-0209	EUDAMED	Class III	Active
Metacross RX	BD-L50120MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60200MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50150MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B40150MR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-18-200	EUDAMED	Class III	Active
R2P Crosstella RX	BD-Q60060ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B15120LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F30060LR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-15006	EUDAMED	Class III	Active
Crosstella RX	BD-F40100LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40150ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q30200ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P40060ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q25040ER	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-02H4R	EUDAMED	Class III	Active
Metacross RX	BD-L60200MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25020LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40080SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60040MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40020MW	EUDAMED	Class IIa	Active
Crosperio RX	BD-B15080MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25020LR	EUDAMED	Class IIa	Active
Crosstella OTW	BD-F50120LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25080MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90020MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P50040ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35080SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80040SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70150MW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S7060M	EUDAMED	Class IIa	Active
Metacross OTW	BD-L50060CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30020LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20200MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q30060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70120CR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B30040MR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-18-400	EUDAMED	Class III	Active
R2P Metacross RX	BD-P30120ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50100MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70040CW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35200LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40200SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50200MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70060SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50100ER	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Kaneka Medical Europe N.V. BE

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Kaneka Corp. US