Certificates & Patents

 

Certificates

Please update with this “bonyf Is certified and compliant according to EN ISO 13485:2016 + A11:2021 and EU-Medical Device Regulation 2017/745. Its products are compliant with EU-MDR 2017/745 and according Article 120 for the Legacy products.

See below bonyf’s current certifications.

 

ISO 9001:2015 – Certificate of Quality Management Systems

EN ISO 13485:2016 – Certificate of Medical Devices — Quality Management Systems

EC Certificate for the Quality Assurance System according to Directive 93/42/EEC

Kosher Certificate issued by Maor Hakashrut, Switzerland, issued 25 November 2021

Patents

bonyf holds the following patents and patent applications on its products and formulations.

AphtoFix ®

Patent No. 2 777 708
Region Patent Granted Europe

NitrAdine® Disinfecting Denture Tabs

Patent No. 1 523 239
Region Patent Granted Europe

NitrAdine® Ortho & Junior Disinfecting Tabs

Patent No. 1 523 239
Region Patent Granted Europe

OlivaFix® Denture Adhesive Cream

Patent No. 2 525 768
Region Patent Granted Europe

OlivaFix® Denture Adhesive Cream & OlivaFix® Gold Denture Adhesive Cream – Petrochemical free formulation

Patent No. 2 929 871
Region Patent Granted Europe

PerioTabs®

Patent Pending No. 15 798 353.7
Region Patent Pending Europe
Patent Pending No. 16/458,728 (divisional of 15/526,247)
Region Patent Pending United States