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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 14 of 21

Device	Model / Reference	Registries	Class	Status
R2P Metacross RX	BD- P40100ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30100MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30020MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P60150ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60040SW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-12-200	EUDAMED	Class III	Active
Neon	BS-30010	EUDAMED	Class III	Active
Crosstella RX	BD-F25100LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30120MR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-20-375	EUDAMED	Class III	Active
Metacross OTW	BD-L50020MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q40040ER	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-40006	EUDAMED	Class III	Active
Metacross OTW	BD-LX2040SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60040LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60080MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70100MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20200LR	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S60100MH	EUDAMED	Class IIa	Active
Senri	BD-S50150L	EUDAMED	Class IIa	Active
R2P Crosstella RX	BD-Q50200ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60040MW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-32506	EUDAMED	Class III	Active
Crosstella RX	BD-F50150MR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-32530	EUDAMED	Class III	Active
Crosstella OTW	BD-F50100LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60060CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80040MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60040LW	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P80040ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25120MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50020SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40150LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40200LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40080MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50100MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P80020ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B30080LR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-8-150	EUDAMED	Class III	Active
Metacross RX	BD-L30200ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40040LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90060SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60020CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90060MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40100CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40200MR	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-03H6RS	EUDAMED	Class III	Active
Metacross RX	BD-L60100ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80020CW	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P30150ER	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