BEUDAMED
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    SE-1230-P

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·MOBERCAS SL·1 device

    RADIOLOGÍA, S.A.

    Manufacturer
    🇪🇸 Spain·SGS Belgium NV

    Sycai Technologies S.L.

    Manufacturer
    🇪🇸 Spain·Kiwa Dare B.V.

    CARDIVAIS S.A.

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

    IONCLINICS & DEIONIC, S.L.

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·4 Devices·TUV Rheinland Italia SRL

    Noventure SL

    Manufacturer
    🇪🇸 Spain·ISTITUTO SUPERIORE DI SANITA' and ISTITUTO SUPERIORE DI SANITA'

    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

    S.E. Carburos Metálicos, S.A.

    Manufacturer
    🇪🇸 Spain·257 Basic UDI-DIs·257 Devices·SGS Belgium NV, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, DNV Product Assurance AS, and DNV Product Assurance AS

    ITH 1343070 1

    Certificate
    MDR QMS·IONCLINICS & DEIONIC, S.L.·TUV Rheinland Italia SRL

    22M00045CRT01

    Certificate
    MDR QMS·Sycai Technologies S.L.·Kiwa Dare B.V.

    ES24/00000401

    Certificate
    MDR QMS·RADIOLOGÍA, S.A.·SGS Belgium NV

    CSQ001623

    Certificate
    MDR QMS·Noventure SL·ISTITUTO SUPERIORE DI SANITA'

    ES/00000039

    Certificate
    MDR QMS·S.E. Carburos Metálicos, S.A.·SGS Belgium NV

    ES23/00000553

    Certificate
    MDR QMS·CARDIVAIS S.A.·SGS Belgium NV

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices