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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 11 of 21

Device	Model / Reference	Registries	Class	Status
Neon Nc	BN-22518	EUDAMED	Class III	Active
Metacross RX	BD-LX0080MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25100MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F30040MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60200SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30100SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40120MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40120CW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-45008	EUDAMED	Class III	Active
Crosstella RX	BD-F60060MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F20040MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60060MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L80080MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40150MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70020MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F50040MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P60080ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70020CR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20200LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20120LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60080SW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q30150ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30080CW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-03H8	EUDAMED	Class III	Active
Metacross RX	BD-L80080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35150LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60020LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX2020CR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35040MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50060SW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-10-400	EUDAMED	Class III	Active
Crosperio OTW	BD-B40150LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40120SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B40200LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40080LW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S8040M	EUDAMED	Class IIa	Active
Crosstella OTW	BD-F30150LW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-6-120	EUDAMED	Class III	Active
Metacross RX	BD-L80040CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60080CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30060MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25200SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20150MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P80080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30120MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F50080LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30150SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50150MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70150MR	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