Is this your brand? Sign in to claim ownership.

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 (1028)

Page 3 of 21

Device	Model / Reference	Registries	Class	Status
RX NC Takeru PTCA Balloon Dilatation Catheter	K170941	FDA 510(k)	Class II	Active
Crosstella RX	BD-F60200MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F60020LR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-25010	EUDAMED	Class III	Active
Metacross RX	BD-L50080CR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-30-400	EUDAMED	Class III	Active
Crosperio OTW	BD-B30080LW	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30150LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30060ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B30120LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40120ER	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-10-275	EUDAMED	Class III	Active
Metacross OTW	BD-L40060SW	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-20-325	EUDAMED	Class III	Active
Crosstella OTW	BD-F30120LW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	352-0508	EUDAMED	Class III	Active
Crosstella RX	BD-F40040LR	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-10-450	EUDAMED	Class III	Active
R2P Crosstella RX	BD-Q20040ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L80020MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L40150MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L60040CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25080MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B25080LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L60120CW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-35010	EUDAMED	Class III	Active
R2P Crosstella RX	BD-Q20020ER	EUDAMEDFDA UDI	Class IIa	Active
Neon Nc	BN-35013	EUDAMED	Class III	Active
Crosstella RX	BD-F20060LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25200MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B35020LW	EUDAMED	Class IIa	Active
Crosperio OTW	BD-B40120LW	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-30-200	EUDAMED	Class III	Active
Metacross OTW	BD-L40150CW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-6-275	EUDAMED	Class III	Active
Metacross OTW	BD-L50150SW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-30-200	EUDAMED	Class III	Active
Crosperio OTW	BD-B25080SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70060ER	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-0308R	EUDAMED	Class III	Active
Crosstella OTW	BD-F30020MW	EUDAMEDFDA UDI	Class IIa	Active
Ed Coil	350-0515	EUDAMED	Class III	Active
Crosperio OTW	BD-B40080MW	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-27508	EUDAMED	Class III	Active
Neon	BS-10006	EUDAMED	Class III	Active
Ed Coil	353-02H6RS	EUDAMED	Class III	Active
Crosperio OTW	BD-B15120LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50060MR	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-30-275	EUDAMED	Class III	Active
Senri	BD-S5060M	EUDAMED	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