BEUDAMED
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    DKK DAI-ICHI SHOMEI CO, LTD

    FDA registration
    DKK DAI-ICHI SHOMEI CO, LTD·5 products·🇯🇵 Japan

    JAPAN OPTICAL CO.,LTD.

    Manufacturer
    🇯🇵 Japan

    NEB-NSETB-8A(NEB-NSETB-8AE)

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·OMRON Healthcare Co., Ltd.·1 device

    NEB-TPC-8A (NEB-TPC-8AE)

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·OMRON Healthcare Co., Ltd.·1 device

    2107788CE06

    Certificate
    MDD Annex II Section 4·ASAHI INTECC CO., LTD.·DEKRA Certification B.V.·2 Basic UDI-DIs

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023

    LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023

    PreXion Corporation

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device

    JM Ortho Corporation

    Manufacturer
    🇯🇵 Japan

    J. MORITA TOKYO MFG. CORP.

    Manufacturer
    🇯🇵 Japan

    ODONTOLOGY DEVICES - OTHER

    Device
    EU MDR · Eu Md Class 2b ·PreXion Corporation·No longer on the market

    MASAHIRO MARUYAMA Inc.

    Manufacturer
    🇯🇵 Japan

    NIDEK.CO.Ltd.,

    Manufacturer
    🇯🇵 Japan·27 Basic UDI-DIs·61 Devices·10 Importers

    NIKON-ESSILOR CO., LTD.

    Manufacturer
    🇯🇵 Japan

    OKAMOTO INDUSTRIES, INC. Ibaraki Plant

    Manufacturer
    🇯🇵 Japan·2 Importers

    Menicon Co., Ltd.

    Manufacturer
    🇯🇵 Japan·4 Importers