BEUDAMED
    8 results · 7ms · Sources: EU EUDAMED, US FDA

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    Shandong Shengquan New Materials Co., Ltd

    Manufacturer
    🇨🇳 China

    Shandong Wego New Life Medical Devices Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device

    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

    Nasal Tampon

    Device
    EU MDR · Eu Md Class 1 ·Shandong Wego New Life Medical Devices Co., Ltd.·Not intended for eu market

    Spatz3 Adjustable Balloon System

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

    Nasal Tampon

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Shandong Wego New Life Medical Devices Co., Ltd.·1 device

    Spatz3 Adjustable Balloon System Insertion Kit

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

    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