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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 20 of 21

Device	Model / Reference	Registries	Class	Status
Metacross RX	BD-L60040ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35120MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F50080MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P60020ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80080CW	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-10-350	EUDAMED	Class III	Active
Crosstella RX	BD-F20200MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30080MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX2040MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60020MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60150SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90020SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40100ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25040MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F50060LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30040MW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-27510	EUDAMED	Class III	Active
Metacross OTW	BD-LX2040CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40020CW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-40018	EUDAMED	Class III	Active
Ed Coil	353-03H6	EUDAMED	Class III	Active
Metacross RX	BD-LX0060ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B40080LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F20020LR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-30-425	EUDAMED	Class III	Active
Senri	BD-S7080LH	EUDAMED	Class IIa	Active
Crosstella OTW	BD-F30200LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70150ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90040CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50020ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B20080LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70040ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80020SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80060CW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-0304R	EUDAMED	Class III	Active
Metacross OTW	BD-L40060CW	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P40020ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60080MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30100LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30120CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40040MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B30120MR	EUDAMEDFDA UDI	Class IIa	Active
Liposorber D	DL-50	EUDAMED	Class IIb	Active
Crosperio RX	BD-B30020MR	EUDAMED	Class IIa	Active
R2P Metacross RX	BD-P30020ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40100MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70020MW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-10-225	EUDAMED	Class III	Active
Metacross OTW	BD-L50100SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25200MW	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