BEUDAMED
    206 results · 19ms · Sources: EU EUDAMED, US FDA

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    ADAS 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADAS 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADAS 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADAS 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADAS 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cojín anillo poliuretano "confort and easy cleaning"

    Device
    EU MDR · Eu Md Class 1 ·ORTOTEX MEDICAL S.L.·On the market·1 country

    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.

    INDIBA S.A.U.

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·2 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    ADAS 3D

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·ADAS3D MEDICAL, S.L.·4 devices

    OPER FILM PROTECT CHG 10 x 12

    Device
    EU MDD · Eu Md Class 3 ·Iberhospitex, S.A.·On the market·6 countries

    OPER FILM PROTECT CHG 8,5 x 11,5

    Device
    EU MDD · Eu Md Class 3 ·Iberhospitex, S.A.·On the market·9 countries

    OPER FILM PROTECT CHG 7 x 8,5 cm

    Device
    EU MDD · Eu Md Class 3 ·Iberhospitex, S.A.·On the market·1 country

    ACTIV CT8

    Device
    EU MDD · Eu Md Class 2a ·INDIBA S.A.U.·On the market·9 countries

    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    FDA Enforcement
    Class II ·Terminated·Sedecal S.A.·August 26, 2015

    MobileDiagnost wDR motorized portable diagnostic X-ray systems.

    FDA Enforcement
    Class II ·Terminated·Sedecal S.A.·February 11, 2015

    Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

    FDA Enforcement
    Class II ·Terminated·Sedecal S.A.·March 16, 2016

    Sedecal NOVA FA DR System. for diagnostic radiography.

    FDA Enforcement
    Class II ·Ongoing·Sedecal S.A.·November 28, 2018

    biokitHSV-2 Rapid Test, REF: 300028001

    FDA Enforcement
    Class II ·Ongoing·Biokit, S.A.·February 1, 2023

    QUALITYLINE,S.L.

    Authorized representative
    🇪🇸 Spain·1 Manufacturer

    Ivonne Richaud

    Authorized representative
    🇪🇸 Spain·1 Manufacturer·90 Devices