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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 15 of 21

Device	Model / Reference	Registries	Class	Status
R2P Metacross RX	BD-P30060ER	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-8-200	EUDAMED	Class III	Active
Crosstella RX	BD-F30100LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60060LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B40120MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L80060CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX2020SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30060CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30020MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B30200MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70100SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50080MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q60020ER	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-0408R	EUDAMED	Class III	Active
Metacross RX	BD-L60200ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B15120MR	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-02H4	EUDAMED	Class III	Active
Metacross RX	BD-L30120CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40200MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40200CW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-15008	EUDAMED	Class III	Active
Metacross OTW	BD-LX0040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70080SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L80020CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70200ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50200MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX0080MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50120CW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-18-350	EUDAMED	Class III	Active
Crosperio RX	BD-B25200MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40020ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35120LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50120CR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q60100ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70150CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60200MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25120LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25150LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX0040ER	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-35020	EUDAMED	Class III	Active
Metacross OTW	BD-L40040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX0080ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40020SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60120MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30200SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30020ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P60120ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35080LR	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