BEUDAMED
    8,375 results · 40ms · Sources: EU EUDAMED, US FDA

    StrykerPR3324 (GR, VG) - 4MM 60 DEG. AGG SERR BLADE

    FDA registration
    ISOMEDIX OPERATIONS INC·1 product·🇺🇸 United States

    StrykerPR3324 (GR, VG) - 4MM 60 DEG. AGG SERR BLADE

    FDA registration
    STERIS ISOMEDIX PUERTO RICO, INC.·1 product·🇺🇸 United States

    DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

    FDA 510(k)
    FDA Class 2 ·Immunology

    FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

    FDA 510(k)
    FDA Class 2 ·Immunology

    CR-03-1156-859-24

    Certificate
    MDR QMS·CGI Suomi Oy·Eurofins Electric & Electronics Finland Oy

    C-01-1156-735-20

    Certificate
    MDD Annex II (excluding section 4)·CGI Suomi Oy·Eurofins Electric & Electronics Finland Oy·2 Basic UDI-DIs

    IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·1 device

    Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

    IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

    Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·1 device

    DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

    FDA 510(k)
    FDA Class 2 ·Hematology

    AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BR60 Hematology Control，SC-CAL RET Hematology Calibrator

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·14 devices

    i-STAT

    FDA UDI
    ABBOTT POINT OF CARE INC.·10054749001917·CARTRIDGE, CHEM8+

    ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Chromogranin A

    FDA classification
    FDA Class 2 ·Chromogranin A

    Curo L5

    FDA UDI
    KPI HEALTHCARE, INC.·00850006113064·CURO L5 Glucose Strip