BEUDAMED
    7,890 results · 46ms · Sources: EU EUDAMED, US FDA

    EPT 0477.MDD.19/3104.1

    Certificate
    MDD Annex II (excluding section 4)·Labomar S.p.A.·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI

    Implant, Auditory Brainstem

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT

    ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

    FDA 510(k)
    FDA Class 2 ·Hematology

    GCE, s.r.o.

    Authorized representative
    🇨🇿 Czechia·1 Manufacturer

    V1 105961 0002

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Ace Medical Technology Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE

    BioButton At-Home Kit with Power Adaptor

    FDA UDI
    BIOINTELLISENSE, INC.·00850005949312·BioButton At-Home Kit with Power Adaptor

    APLICARE

    FDA UDI
    MEDLINE INDUSTRIES, INC.·00618407611066·SWABSTCK, BENZOIN TINCTURE, 1/PK, STRL

    BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton

    FDA UDI
    BIOINTELLISENSE, INC.·00850005949343·BioButton At-Home Kit with Power Adaptor, Adhes...

    BioButton At-Home Kit

    FDA UDI
    BIOINTELLISENSE, INC.·00850005949381·BioButton At-Home Kit

    BioButton v3 (BBN-r, different batch, Individual Pack)

    FDA UDI
    BIOINTELLISENSE, INC.·00850005949220·Note: 00850005949220 (Model# BIOST06040) is equ...

    BioButton At-Home Kit with Power Adaptor and Adhesives

    FDA UDI
    BIOINTELLISENSE, INC.·00850005949404·BioButton At-Home Kit with Power Adaptor and Ad...

    Medline

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10884389123430·ADAPTER,CATHETER/SYRINGE/LUER,STERILE

    BioButton At-Home Kit with Adhesives and BioButton

    FDA UDI
    BIOINTELLISENSE, INC.·00850005949367·BioButton At-Home Kit with Adhesives and BioButton

    Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PURITAN FOAM TIP SWAB MODEL 2197

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE

    FDA 510(k)
    FDA Class 1 ·Hematology

    Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DOCUMENT THYROID CAL*VER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RYNEL MEDICAL FOAM

    FDA 510(k)
    FDA Class 1 ·General Hospital