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Verfügt OdySight über die CE-Kennzeichnung?

Die CE-Kennzeichnung zeigt an, dass ein Produkt den europäischen Rechtsvorschriften entspricht, sodass es im Europäischen Wirtschaftsraum frei verkehren kann. Es gibt mehrere Klassen von Medizinprodukten – von Klasse I (geringes Risiko) bis Klasse III (hohes Risiko).

OdySight ist ein Medizinprodukt der Klasse I, das gemäß den Vorschriften für Medizinprodukte der geltenden Richtlinie 93/42/EG mit dem CE-Zeichen versehen ist (Selbstzertifizierung). Unser Qualitätsmanagementsystem entspricht der Norm ISO 13485:2016.

Nächste Frage
Wie stellt die Anwendung die Reproduzierbarkeit der Tests sicher?