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

    Ai-Pex

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

    Angio-I(A I) Detection Kit(CLIA)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

    Spatz3 Adjustable Balloon System

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

    1000169818

    Certificate
    MDR QMS·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    170783435

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    170781760

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    3901646CE01

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

    7406GB410210510A

    Certificate
    MDD Annex II (excluding section 4)·EyeYon Medical Ltd.·DNV MEDCERT GmbH·2 Basic UDI-DIs

    542544 MDR2017P

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·1 Basic UDI-DI

    170781760

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·1 Basic UDI-DI

    170769617

    Certificate
    MDD Annex II Section 4·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs

    170771902

    Certificate
    MDD Annex II Section 4·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·3 Basic UDI-DIs

    26445

    Certificate
    MDD Annex II (excluding section 4)·Synergy Spine Solutions Inc.·GMED SAS·12 Basic UDI-DIs

    2125546CE01

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

    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

    G1 004957 0002

    Certificate
    MDD Annex II (excluding section 4)·Insight Lifetech Co., Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

    G7 004957 0003

    Certificate
    MDD Annex II Section 4·Insight Lifetech Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    G1 055809 0022

    Certificate
    MDD Annex II (excluding section 4)·Gentec (Shanghai) Corporation·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

    6085114CE01

    Certificate
    MDD Annex II (excluding section 4)·Henan Simedice Biotechnologies Co.,Ltd.·DEKRA Certification B.V.·2 Basic UDI-DIs