BEUDAMED
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    Spatz FGIA Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

    Spatz3 Adjustable Balloon System

    Device
    EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·On the market·20 countries

    170222 QS/NB

    Certificate
    MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

    Spatz3 Adjustable Balloon System Insertion Kit

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

    Breathing Reservoir Bag (Test Lung)

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

    Breathing Reservoir Bag (Test Lung)

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

    Ventilator Tubing / Adult Breathing Tubing

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

    Ventilator Tubing / Child Breathing Tubing

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

    Ventilator Tubing / Infant Breathing Tubing

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

    Hyper-CL

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

    FFRangio System

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

    CS-B0018B2C

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Biodenta Swiss AG·1 device

    HA-B2040B1H

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Biodenta Swiss AG·1 device

    AB-B040GH2A

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Biodenta Swiss AG·1 device

    I-PA41B2L10A

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Biodenta Swiss AG·1 device

    AB-B040GH2N

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Biodenta Swiss AG·1 device

    EndoArt

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·EyeYon Medical Ltd.·1 device

    IOPtimate

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·IOPtima Ltd.·1 device

    9909-2017-CE-RGC-NA-PS

    Certificate
    MDD Annex II (excluding section 4)·VADI Medical Technology Co., Ltd.·DNV Product Assurance AS·5 Basic UDI-DIs

    3901646CE01

    Certificate
    MDD Annex II (excluding section 4)·CathWorks Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI