BEUDAMED
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    N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297

    FDA Enforcement
    Class II ·Ongoing·SIEMENS HEALTHCARE DIAGNOSTICS INC·October 26, 2022

    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

    FDA Enforcement
    Class II ·Ongoing·SIEMENS HEALTHCARE DIAGNOSTICS INC·October 26, 2022

    GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.

    FDA Enforcement
    Class II ·Ongoing·GRAPHENANO DENTAL SL·March 6, 2024

    ETNIA BARCELONA

    Device
    EU MDR · Eu Md Class 1 ·Etnia Eyewear Culture S.L·On the market·32 countries

    WEIGERT’S HAEMATOXYLIN A (1 x 500mL)

    Device
    EU IVDR · Eu Ivd Class A ·QUIMICA CLINICA APLICADA S.A.·On the market·32 countries

    REAGENT 1. N-ACETYL-L-CYSTEINE

    Device
    EU IVDR · Eu Ivd Class A ·Laboratorios Conda S.A.·On the market·32 countries

    Tecnoclínic SA

    Manufacturer
    🇪🇸 Spain·25 Basic UDI-DIs·83 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

    Medical Cables S.L.

    Manufacturer
    🇪🇸 Spain·331 Basic UDI-DIs·331 Devices·SGS Belgium NV and SGS Belgium NV

    PROMECHI, S.L.

    Manufacturer
    🇪🇸 Spain·15 Basic UDI-DIs·15 Devices·SGS Belgium NV and SGS Belgium NV

    Biosurgical S.L

    Manufacturer
    🇪🇸 Spain·4 Basic UDI-DIs·4 Devices·SGS Belgium NV and SGS Belgium NV

    RADIOLOGÍA, S.A.

    Manufacturer
    🇪🇸 Spain·SGS Belgium NV

    Phi Med Europe

    Manufacturer
    🇪🇸 Spain·6 Basic UDI-DIs·6 Devices·SGS Belgium NV

    Alma IT Systems, S.L:

    Manufacturer
    🇪🇸 Spain·1 Basic UDI-DI·1 Device·SGS Belgium NV

    GMV SOLUCIONES GLOBALES INERNET S.A.U.

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·2 Devices·SGS Belgium NV

    AIR LIQUIDE HEALTHCARE ESPAÑA, SL

    Manufacturer
    🇪🇸 Spain·7 Basic UDI-DIs·7 Devices·SGS Belgium NV

    CARDIVAIS S.A.

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·28 Devices·SGS Belgium NV

    Iberhospitex, S.A.

    Manufacturer
    🇪🇸 Spain·49 Basic UDI-DIs·54 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    COVID-19 MPX 1-Step N Gene PCR. CE-IVD. Tubo 96 Reacciones

    Device
    EU IVDD · Eu Ivd General ·SISTEMAS GENOMICOS. S.L.·On the market

    COVID-19 MPX 1-Step N Gene PCR Lyo. CE-IVD. Tubo 96 Reacciones

    Device
    EU IVDD · Eu Ivd General ·SISTEMAS GENOMICOS. S.L.·On the market

    COVID-19 MPX 1-Step N Gene PCR H. CE-IVD. Placa 96 reacciones.

    Device
    EU IVDD · Eu Ivd General ·SISTEMAS GENOMICOS. S.L.·On the market