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    IBIS TAKASHIMA CO. LTD.

    FDA registration
    IBIS TAKASHIMA CO. LTD.·1 product·🇯🇵 Japan

    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

    TONOREF III

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·1 device

    OPD-Scan III

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·1 device

    HEXAMATE Factor XIII-Control I/II

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.·1 device

    ASAHI INTECC CO., LTD.

    Manufacturer
    🇯🇵 Japan·1371 Basic UDI-DIs·1371 Devices·1 Importer·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    GUNZE LIMITED

    Manufacturer
    🇯🇵 Japan·69 Basic UDI-DIs·69 Devices·3 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    TOP Corporation

    Manufacturer
    🇯🇵 Japan·39 Basic UDI-DIs·97 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    SEIKAGAKU CORPORATION

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    SB-KAWASUMI LABORATORIES, INC.

    Manufacturer
    🇯🇵 Japan·408 Basic UDI-DIs·426 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    Tokai Medical Products, Inc.

    Manufacturer
    🇯🇵 Japan·71 Basic UDI-DIs·71 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV

    Sun Medical Co., Ltd.

    Manufacturer
    🇯🇵 Japan·41 Basic UDI-DIs·55 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    JIMRO Co., Ltd.

    Manufacturer
    🇯🇵 Japan·3 Basic UDI-DIs·3 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    Asahi Polyslider Company, Limited

    Manufacturer
    🇯🇵 Japan·14 Basic UDI-DIs·17 Devices·SGS Belgium NV and SGS Belgium NV

    Takagi seiko

    Manufacturer
    🇯🇵 Japan·14 Basic UDI-DIs·29 Devices·4 Importers·SGS Belgium NV, SGS FIMKO OY, SGS FIMKO OY, and SGS FIMKO OY

    PIOLAX MEDICAL DEVICES, INC.

    Manufacturer
    🇯🇵 Japan·22 Basic UDI-DIs·22 Devices·2 Importers·SGS Belgium NV

    Otsuka Electronics Co., Ltd.

    Manufacturer
    🇯🇵 Japan·6 Basic UDI-DIs·6 Devices·5 Importers·TÜV SÜD Product Service GmbH

    HAKKO CO., LTD.

    Manufacturer
    🇯🇵 Japan·2 Basic UDI-DIs·2 Devices·3 Importers·BSI Group The Netherlands B.V.

    Ziosoft, Inc.

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH

    AIR WATER REALIZE INC.

    Manufacturer
    🇯🇵 Japan·55 Basic UDI-DIs·55 Devices·7 Importers·TÜV Rheinland LGA Products GmbH