DJ bonyf AG receives the EU-MDR Certification Class IIa for PerioCream
bonyf NV / Key word(s): Product Launch/Incoming Orders bonyf AG receives the EU-MDR Certification Class IIa for PerioCream 15-Oct-2025 / 15:23 CET/CEST =---------------------------------------------------------------------------------------------------------------------- bonyf AG receives the EU-MDR Certification Class IIa for PerioCream Knokke-Heist (Belgium), 15 October 2025, 6:00 a.m.; bonyf NV (Euronext Paris Ticker: MLBON), a leader in dental consumer goods, professional dental consumables and dermatological solutions, announces today that its brand, PerioCream, a mucoadhesive formulation based on NitrAdine®, applied by dental professionals as an adjunct to Scaling & Root Planing (SRP) has been granted a certification as a Class IIa medical device according to Medical Device Regulation (EU) 2017/745 Annex IX Chapter I+III. The certification, issued by DEKRA Certification GmbH, Germany, Notified Body (ID Number: 0124) on September the 17th, 2025, releases PerioCream Periodontal Paste to dental professionals and practitioners across the world. The Medical Device Regulation (EU) 2017/745 is one of the world's most robust health tech regulations, and it plays a vital role in ensuring medical devices meet the highest standards. It has replaced the Medical Device Directive (MDD) and brings a series of important improvements to conformity assessment for medical devices with the scope to ensure the quality, safety, performance and reliability of medical devices placed on the European Market; strengthen transparency of information related to medical devices for consumers and practitioners; enhance vigilance and market surveillance of devices in use. DEKRA Certification GmbH based in Germany with worldwide presence, is the notified Body of bonyf AG. We got the MDR certification from DEKRA including PerioCream, based on the sampling plan for reviews of class IIa devices. For the UK market, European CE marking is currently accepted until specified deadlines and product risk classification. A UKRP (UK Representative) was already designated, and UK resellers can contact bonyf AG to obtain more information. For the US market, bonyf AG initiated the certification process with FDA and currently bonyf AG is on track with expected certification by the US FDA beginning 2026. What is PerioCream? PerioCream Periodontal Paste is an adjunct to scaling and root planing (SRP) treatment applied by dental professionals on the gum line. PerioCream Periodontal Paste acts as a protective barrier by isolating inflamed gingiva and irritated oral tissues to prevent bacterial recolonization, help reduce bleeding and enhance natural healing. The product is clinically proven to significantly reduce pain after SRP, enhance patient comfort and improve the overall SRP experience. About bonyf bonyf NV is a Belgian Euronext Paris listed company (Ticker: MLBON) specialized in the development and distribution of high-quality oral and denture care products, serving both professional and consumer markets. Through its fully owned subsidiaries bonyf AG (Liechtenstein) and bonyf Production AG (Switzerland), the company is accelerating its international reach. With a focus on innovation, sustainability, and clinical performance, bonyf is rapidly expanding its footprint across Europe and North America. Annex to the EU Certificate no. 50537-60-00-02 Cureus Journal of Medical Science ResearchGate European Institute for Medical Studies (EIMS), St. Julian's, Malta bonyf's strengths -- Products with patented formulations -- Produced in Switzerland compliant with stringent international quality regulations -- Proven clinical efficacy -- Commercial presence in 37 countries -- Prospects for solid growth and rapid profitability -- A fast-growing oral and dental care market About bonyf bonyf is a European innovator in oral and dermatological care, developing clinically validated solutions for dental professionals, pharmacies, and consumers. Listed on Euronext Paris (MLBON), bonyf is headquartered in Knokke, Belgium, and operates with a growing global presence across Europe, Asia, and the Americas. For more information, visit bonyf.com or contact investor@bonyf.com. bonyf Jean-Pierre Bogaert investor@bonyf.com
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File: EN_PR_bonyf AG receives the EU-MDR Certification Class IIa for PerioCream.
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Dissemination of a Financial Wire News, transmitted by EQS Group. The issuer is solely responsible for the content of this announcement.
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Language: English
Issuer: bonyf NV
Kalvekeetdijk 179, box 105
8300 Knokke-Heist
Belgium
Phone: +41 79 412 42 79
E-mail: president@bonyf.com
Internet: www.bonyf.com
ISIN: BE6333353298
EQS News ID: 2213580
End of Announcement - EQS News Service
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2213580 15-Oct-2025 CET/CEST
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October 15, 2025 09:24 ET (13:24 GMT)
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