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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 13 of 21

Device	Model / Reference	Registries	Class	Status
IKAZUCHI Zero	ZE-6-100F	EUDAMED	Class III	Active
Ed Coil	350-0620	EUDAMED	Class III	Active
Metacross OTW	BD-L70120MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90060CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30040LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30100CW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35080MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q40060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60020SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX0060MR	EUDAMEDFDA UDI	Class IIa	Active
Liposorber D	DL-75	EUDAMED	Class IIb	Active
Metacross RX	BD-L70060CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60120MR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-30030	EUDAMED	Class III	Active
R2P Crosstella RX	BD-Q30020ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90080CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40060MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25200MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P50120ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90020ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20040SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20200MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60060MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90020MW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-42520	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-15-250	EUDAMED	Class III	Active
Metacross RX	BD-L60060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60060SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50200CW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-30-225	EUDAMED	Class III	Active
Crosstella OTW	BD-F30150MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	352-1620	EUDAMED	Class III	Active
Raiden3	RD3-15-200	EUDAMED	Class III	Active
Crosstella RX	BD-F20120MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P50100ER	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-15-400	EUDAMED	Class III	Active
Crosstella OTW	BD-F50200LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25040LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30150MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25020MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50120ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40120MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70080CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30020SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B40040LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70040MR	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S3040M	EUDAMED	Class IIa	Active
Crosperio RX	BD-B20040MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50080ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P70040ER	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