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Registering Dental Floss in EU

  • 1.  Registering Dental Floss in EU

    Posted 27-Jul-2011 08:18
    According to MEDDEV 2.1/1 Dental Floss is not a medical device but a device intended to have a cosmetic or toiletry purpose.  But the US FDA classifies Dental Floss as a Class I device 21 CFR 872.6390

    How can one go about registering dental floss in EU?



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    Karan Jhaveri
    QA/RA Specialist

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