BEUDAMED
    9 results · 123ms · Sources: EU EUDAMED, US FDA

    NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Shanghai International Holding Corp. GmbH(Europe)

    Authorized representative
    🇩🇪 Germany·637 Manufacturers·33064 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Self-Fitting Air-Conduction Hearing Aid, Prescription

    FDA classification
    FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Prescription

    Self-Fitting Air-Conduction Hearing Aid, Over The Counter

    FDA classification
    FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Over The Counter

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

    MedEnvoy Global BV

    Importer
    🇳🇱 Netherlands·234 Manufacturers