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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 16 of 21

Device	Model / Reference	Registries	Class	Status
Crosstella OTW	BD-F50060LW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	352-1630RS	EUDAMED	Class III	Active
R2P Metacross RX	BD-P50150ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40080MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-0930RS	EUDAMED	Class III	Active
Crosstella RX	BD-F50020MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30040SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F50020LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50200SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-LX0040CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40100SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40200SW	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-37515	EUDAMED	Class III	Active
IKAZUCHI Zero	ZE-12-275	EUDAMED	Class III	Active
Metacross RX	BD-L90040ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P70200ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P70150ER	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-30-300	EUDAMED	Class III	Active
Metacross OTW	BD-L50120MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-0930R	EUDAMED	Class III	Active
Crosperio OTW	BD-B40080LW	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q25100ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P70120ER	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S4060M	EUDAMED	Class IIa	Active
Neon Nc	BN-32520	EUDAMED	Class III	Active
Metacross OTW	BD-L40120SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25100MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30060SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L70060CW	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P40080ER	EUDAMEDFDA UDI	Class IIa	Active
Liposorber D	DL-100	EUDAMED	Class IIb	Active
Ed Coil	353-0202	EUDAMED	Class III	Active
Metacross RX	BD-LX2020MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20020MR	EUDAMED	Class IIa	Active
Crosstella RX	BD-F40120LR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35150SW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35150MW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-6-150	EUDAMED	Class III	Active
Senri	BD-S60100LH	EUDAMED	Class IIa	Active
R2P Metacross RX	BD-P60040ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P60100ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30080MW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B15020LR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30080MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90080CW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30150SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40020MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60060CR	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