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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 9 of 21

Device	Model / Reference	Registries	Class	Status
Metacross RX	BD-L40040MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50150CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70120CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70060MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30200SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50060MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50060CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30200MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70100CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40040CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60200CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50040MW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-37518	EUDAMED	Class III	Active
Crosstella RX	BD-F60120LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B40040MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60120ER	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	353-0208RS	EUDAMED	Class III	Active
Neon	BS-17520	EUDAMED	Class III	Active
Crosperio OTW	BD-B30040MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	352-0408	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-12-250	EUDAMED	Class III	Active
Metacross OTW	BD-L50100CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30100MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q25120ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50080MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B40120LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70150SW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S7060L	EUDAMED	Class IIa	Active
IKAZUCHI Zero	ZE-6-225	EUDAMED	Class III	Active
R2P Crosstella RX	BD-Q50060ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70100ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40100MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40020LR	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-45018	EUDAMED	Class III	Active
Crosstella RX	BD-F50200LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40060MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B25080LR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P50200ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20120MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60150MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60100CW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	352-0515	EUDAMED	Class III	Active
Metacross OTW	BD-L90080MW	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P40040ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40100CR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B35150MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30120MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B15020SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70080CR	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