BEUDAMED
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    CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

    Device
    EU IVDD · Eu Ivd Self Testing ·Nanjing Genscript Diagnostics Technology Co., Ltd.·On the market

    Nanchang Hua 'an Zhonghui Health Technology Co., LTD.

    Manufacturer
    🇨🇳 China

    Shenzhen Raysight Intelligent Medical Technology Co., Ltd

    Manufacturer
    🇨🇳 China·SGS Belgium NV

    CN23/00002629

    Certificate
    MDR QMS·Shenzhen Raysight Intelligent Medical Technology Co., Ltd·SGS Belgium NV

    1434-IVDD-110/2022

    Certificate
    IVDD Annex III Section 6·Nanjing Genscript Diagnostics Technology Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    ELECTRIC BREAST PUMP

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Guangdong Horigen Mother & Baby Products Co., Ltd.·1 device

    Injection cap

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SCW Medicath Ltd.·1 device

    Pressure Bandage

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SCW Medicath Ltd.·1 device

    Infusion Sets with needless adapter

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SCW Medicath Ltd.·1 device

    Colored piston specialty Syringes

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SCW Medicath Ltd.·1 device

    Dose-control Syringes

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SCW Medicath Ltd.·1 device

    Transradial Introducer Sets

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·SCW Medicath Ltd.·1 device

    Introducer Sets

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·SCW Medicath Ltd.·1 device

    Angiographic Syringes

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·SCW Medicath Ltd.·1 device

    Connecting Tubings

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·SCW Medicath Ltd.·1 device

    Hemostasis Valve Sets

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SCW Medicath Ltd.·1 device

    Balloon Inflation Devices

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·SCW Medicath Ltd.·1 device

    SARS-CoV-2 Neutralizing Antibody Detection Kit (Latex immunochromatography-blocking sandwich method)

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Nanjing Genscript Diagnostics Technology Co., Ltd.·1 device

    Disposable Endoscopic Cutting staplers

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Ningbo Verykind Medical Device Co.,Ltd.·1 device

    G1 092506 0006

    Certificate
    MDD Annex II (excluding section 4)·Guangdong Horigen Mother & Baby Products Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI