BEUDAMED
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    SPOTCHEM II CPK

    Device
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

    SPOTCHEM II CPK

    Device
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

    Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012

    FDA Enforcement
    Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

    SPOTCHEM II CPK

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    SPOTCHEM II CPK

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device