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    Filters Notified Body: Bsi Group The Netherlands B.V. ×

    Atomo Diagnostics Limited

    Manufacturer
    🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES

    Device
    EU MDD · Eu Md Class 2a ·Med-Logics, Inc.·On the market·32 countries

    IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC

    Device
    EU MDD · Eu Md Class 2b ·AST VisionCare Inc.·On the market·10 countries

    K3Pro Temporary abutment

    Device
    EU MDD · Eu Md Class 2b ·Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG·On the market·8 countries

    PTA BALLOON DILATATION CATHETERS

    Device
    EU MDD · Eu Md Class 2a ·BrosMed Medical Co., Ltd·On the market·1 country

    IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC

    Device
    EU MDD · Eu Md Class 2b ·AST VisionCare Inc.·On the market·10 countries

    IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC

    Device
    EU MDD · Eu Md Class 2b ·AST VisionCare Inc.·On the market·10 countries

    EUROSILICONE S.A.S

    Device
    EU MDD · Eu Md Class 2a ·EUROSILICONE SAS·On the market·32 countries

    Sapphire NC

    Device
    EU MDD · Eu Md Class 3 ·OrbusNeich Medical, B.V.·On the market·28 countries

    Simplitude ByMe

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

    Simplitude ByMe

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

    Asqelio EDOF Toric Preloaded IOL Delivery System

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·AST VisionCare Inc.·1 device

    K3Pro Temporary abutment

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG·1 device

    CANNULA

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Med-Logics, Inc.·1 device

    Polux PTA Balloon Dilatation Catheter

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·BrosMed Medical Co., Ltd·1 device

    CE611677

    Certificate
    MDD Annex II Section 4·Lifetech Scientific (Shenzhen) Co., Ltd.·BSI Group The Netherlands B.V.·23 Basic UDI-DIs

    716015

    Certificate
    IVDD Annex IV Section 4·Atomo Diagnostics Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

    637070

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Atomo Diagnostics Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

    HIV Self Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·1 device

    HIV Self Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·1 device