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KANEKA Corporation

Active in EUDAMED

Japanfrom SRN EUDAMED FDA SRN JP-MF-000022143

Devices
70
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment
Authorised rep.
Kaneka Medical Europe N.V.BE

Catalogue70

Newest first, rows 1-50 of 70

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  • Crosperio OTW Ref BD-B20020MW

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neon Nc Ref BN-30008

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Metacross OTW Ref BD-L30150MW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Crosperio OTW Ref BD-B30020SW

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • R2P Crosstella RX Ref BD-Q25060ER

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Metacross OTW Ref BD-L80060MW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Crosperio OTW Ref BD-B30200LW

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Crosperio OTW Ref BD-B25120LW

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Crosstella OTW Ref BD-F40120MW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Senri Ref BD-S8060LH

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Crosstella RX Ref BD-F25080LR

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • OTW Takeru PTCA Balloon Dilatation Catheter Ref K172264

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • RX Takeru Balloon Dilatation Catheter Ref K163372

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • RX NC Takeru PTCA Balloon Dilatation Catheter Ref K170941

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Crosperio OTW Ref BD-B30080LW

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Neon Ref BS-10006

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Neon Ref BS-25012

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Crosperio RX Ref BD-B35200LR

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Neon Nc Ref BN-30013

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Metacross OTW Ref BD-L40040SW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Metacross RX Ref BD-L80020ER

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Crosperio RX Ref BD-B35020MR

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Metacross OTW Ref BD-LX0060MW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Metacross OTW Ref BD-LX0020MW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Metacross OTW Ref BD-LX0040SW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Metacross RX Ref BD-L30040CR

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Neon Nc Ref BN-42513

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Senri Ref BD-S50120L

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Raiden3 Ref RD3-10-275

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Crosstella OTW Ref BD-F60020MW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Metacross OTW Ref BD-L70120CW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • R2P Crosstella RX Ref BD-Q25120ER

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • R2P Crosstella RX Ref BD-Q50060ER

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Crosstella RX Ref BD-F50200LR

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Crosperio RX Ref BD-B25080LR

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Metacross RX Ref BD-LX0040MR

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Raiden3 Ref RD3-13-325

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Metacross RX Ref BD-L70060MR

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Metacross RX Ref BD-L70020MR

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Ed Coil Ref 350-0730RS

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Ed Coil Ref 353-0203R

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Metacross OTW Ref BD-L70200CW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Ed Coil Ref 350-0620

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Metacross OTW Ref BD-L50200CW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Crosstella OTW Ref BD-F30150MW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Crosstella OTW Ref BD-F40080MW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Crosstella RX Ref BD-F40200MR

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Metacross RX Ref BD-L30120CR

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Metacross OTW Ref BD-L50200SW

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Liposorber D Ref DL-100

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

Rows 1-50 of 70

Showing 1-50 of 70

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
JP-MF-000022143
DUNS number
690535406
EUDAMED status
Active
EUDAMED registered name
KANEKA Corporation
Registered address
3-18, 2-chome Nakanoshima, 530-8288, Osaka-city, Japan
Phone
+815031339235
PRRC contact
Kazuaki Sanaka(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Kaneka Corp. JP

Frequently asked questions

How many devices does KANEKA Corporation have in the registry?

The registry currently lists 70 devices for KANEKA Corporation. Devices recorded under merged duplicate company entries are counted once.

Which registries list KANEKA Corporation's devices?

Among its 50 most recently registered devices, KANEKA Corporation has devices listed in EUDAMED (47 devices), FDA 510(k) (3 devices) and FDA GUDID (31 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do KANEKA Corporation's devices fall under?

Among its 50 most recently registered devices, the classes recorded for KANEKA Corporation's devices are Class IIa, Class IIb, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from KANEKA Corporation in the registry?

The most recently registered devices listed for KANEKA Corporation include Crosperio OTW, NEON NC, Metacross OTW and R2P Crosstella RX.

Which FDA establishments are linked to KANEKA Corporation?

1 FDA establishment is linked to KANEKA Corporation in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.