BEUDAMED
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    Empatica S.r.L.

    Manufacturer
    🇮🇹 Italy·1 Basic UDI-DI·1 Device·TUV Rheinland Italia SRL and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

    EMPATICA S.r.l.

    FDA registration
    EMPATICA S.r.l.·11 products·🇮🇹 Italy

    COMPLETE VITAL SIGNS TELEMETRY SYSTEMS

    Device
    EU MDD · Eu Md Class 2a ·Empatica S.r.L.·On the market·32 countries

    EMBRACE2 WATCH

    FDA Adverse Event
    Malfunction ·EMPATICA S.R.L.·Product code POS·February 16, 2024

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    FDA Recall
    Open, Classified ·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023

    E4

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Empatica S.r.L.·1 device

    ITH 1986726 1

    Certificate
    MDR QMS·Empatica S.r.L.·TUV Rheinland Italia SRL

    1876/MDD

    Certificate
    MDD Annex II (excluding section 4)·Empatica S.r.L.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·1 Basic UDI-DI