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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 12 of 21

Device	Model / Reference	Registries	Class	Status
Metacross OTW	BD-L30040MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-0203R	EUDAMED	Class III	Active
R2P Metacross RX	BD-P80060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30020CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60020MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20020LR	EUDAMED	Class IIa	Active
Metacross OTW	BD-L30040CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX0080CR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25200LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30080ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L80040MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35040LW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-20013	EUDAMED	Class III	Active
Metacross OTW	BD-LX0080SW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S4040M	EUDAMED	Class IIa	Active
Metacross RX	BD-L50200ER	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-15-375	EUDAMED	Class III	Active
Crosstella OTW	BD-F25080LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25100LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20150LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20080MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60040MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P30040ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30040SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX2040CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60020CR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25040LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50040CW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-1615RS	EUDAMED	Class III	Active
Metacross RX	BD-L40040ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50060MW	EUDAMEDFDA UDI	Class IIa	Active
ELECTRO DETACH GENERATOR v4	347-404R	EUDAMED	Class IIb	Active
Crosstella RX	BD-F30150LR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-20-200	EUDAMED	Class III	Active
Crosperio RX	BD-B30040LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX2020ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50040ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F30020LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20020LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70200CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F30200MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50100MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40020MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25120MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35120SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40060LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B15020MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30150ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90060CR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-13-225	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

Kaneka Medical Europe N.V. BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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FDA Establishments (1)

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

Kaneka Corp. US