Gjeldende nedklassefisering, lukkes eller ikke:
Fikk svar av Uroviu om klassefisering av eksisterende fleks, de gir virkelig hÄp at bluelight kan nedgraderes. Uroviu har godkjente FDA scope i USA.
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Fra Uroviu idag:
Thank you for your interest in our products!
Our device is a Class II device and its indication for use is White Light cystoscopy only. (FDA 510K)
With regards to Blue Light, you may find this information useful.
Are you interested in distributing our product in Norway?
Look forward to hearing from you.
Kind regards,
â
Nai Otero UroViu Corp - Customer Service Manager
E nai@uroviu.com
O 650-878-6686 C 609-970-9145