BEUDAMED
    16 results · 18ms · Sources: EU EUDAMED, US FDA

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    Anti-Fyb Coombs-reactive, polyclonal, human

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·On the market

    Anti-Fyb Coombs-reactive, polyclonal, human

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·On the market

    Anti-Fyb for card method, Coombs-reactive, polyclonal, human

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·On the market

    Gründler GmbH

    Manufacturer
    🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY

    Fiagon GmbH

    Manufacturer
    🇩🇪 Germany·14 Basic UDI-DIs·33 Devices·SGS FIMKO OY

    PAUSCH Medical GmbH

    Manufacturer
    🇩🇪 Germany·SGS FIMKO OY

    Rhyk Technologies GmbH

    Manufacturer
    🇩🇪 Germany·SGS FIMKO OY

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016

    Anti-Fyb Coombs-reactive, polyclonal, human

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·1 device

    Anti-Fyb Coombs-reactive, polyclonal, human

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·1 device

    Anti-Fyb for card method, Coombs-reactive, polyclonal, human

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·1 device

    FI24/00000064

    Certificate
    MDR QMS·Fiagon GmbH·SGS FIMKO OY

    FI23/00000052

    Certificate
    MDR QMS·PAUSCH Medical GmbH·SGS FIMKO OY

    FI23/00000046

    Certificate
    MDR QMS·Rhyk Technologies GmbH·SGS FIMKO OY

    FI23/00000013

    Certificate
    MDR QMS·Gründler GmbH·SGS FIMKO OY