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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 6 of 21

Device	Model / Reference	Registries	Class	Status
Crosperio OTW	BD-B40200MW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-15-150	EUDAMED	Class III	Active
Ed Coil	353-0408	EUDAMED	Class III	Active
Metacross OTW	BD-L50080SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20150SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L80020ER	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S5040L	EUDAMED	Class IIa	Active
Senri	BD-S8060L	EUDAMED	Class IIa	Active
Crosperio RX	BD-B20120LR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q50120ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B30150LR	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S20150L	EUDAMED	Class IIa	Active
Crosstella OTW	BD-F20100LW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	352-1030	EUDAMED	Class III	Active
Neon	BS-30012	EUDAMED	Class III	Active
Crosstella OTW	BD-F25120MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35040LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35020MR	EUDAMED	Class IIa	Active
Metacross OTW	BD-LX0060MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40060MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P30200ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50200CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70100MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q30080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F20120LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60100MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B15120MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35040MW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S7080L	EUDAMED	Class IIa	Active
Metacross OTW	BD-LX0020MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q40120ER	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-0404	EUDAMED	Class III	Active
Metacross OTW	BD-L70120SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35020SW	EUDAMED	Class IIa	Active
Crosperio RX	BD-B40200MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L80040ER	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-35018	EUDAMED	Class III	Active
Raiden3	RD3-8-400	EUDAMED	Class III	Active
Metacross OTW	BD-L60020MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40060MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B15020LW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-25015	EUDAMED	Class III	Active
Metacross RX	BD-L70120ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX0040SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90020CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30040CR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-20-150	EUDAMED	Class III	Active
Metacross OTW	BD-L70020CW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30120SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35040SW	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