جارٍ التحميل…
Manufacturer and distributor of dental disposables based in Chiasso, Switzerland since 1979.
سويسراتأسست عام 1979شركة مصنِّعة · رعاية صحيةISO 13485ISO 9001ISO 14001
declaration conformity
Declaration of Conformity for PRIME|ONE Micro Applicators according to EU Medical Device Regulation 2017/745, confirming compliance with safety, performance, and relevant ISO standards.
declaration conformity
Declaration of Conformity for PRIME|ONE COOL BREATH FACEMASKS according to EU Medical Device Regulation 2017/745, confirming compliance with EN 14683:2025 and other relevant safety and performance standards.
declaration conformity
Declaration of Conformity for Paradise Face Mask, confirming compliance with EU Medical Device Regulation 2017/745 for Class I medical devices, including adherence to EN 14683:2025 and various ISO standards.
declaration conformity
Declaration of Conformity for Perfect Fit Face Masks, confirming compliance with EU Medical Device Regulation 2017/745 and relevant EN/ISO standards for Class 1 medical devices.
declaration conformity
Declaration of Conformity for SMART ONE Face Masks, confirming compliance with EU Medical Device Regulation 2017/745 and relevant EN/ISO standards for Class I medical devices.
declaration conformity
Declaration of Conformity for PRIME|ONE Oat Coated Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat. III).
declaration conformity
Declaration of Conformity for ART|ONE SUNFLOWER LATEX GLOVES, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Category III).
declaration conformity
EU Declaration of Conformity for SMART|ONE Extra Sensitive Latex Gloves, confirming compliance with Medical Device Regulation (EU) 2017/745 and various EN/ISO/ASTM standards.
declaration conformity
Declaration of Conformity for Bio Nitrile Gloves (article series GLOBY53-AKZ-TL) issued by Akzenta International SA, confirming compliance with EU MDR 2017/745 (Class I) and PPE Regulation (EU) 2016/425.
declaration conformity
Declaration of Conformity for Pure Planet Edition Biodegradable Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 and various EN/ISO standards for medical and protective equipment.
declaration conformity
Declaration of Conformity for SMART | ONE Ice Blue Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat III).
declaration conformity
Declaration of Conformity for SMART|ONE Lavender Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat III).
declaration conformity
Declaration of Conformity for SMART|ONE White Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat III).
declaration conformity
Declaration of Conformity for ART|ONE Fuchsia Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat. III).
declaration conformity
Declaration of Conformity for Mamba Green Art|One Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Category III).
declaration conformity
Declaration of Conformity for Art|One Pink Panther Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat. III).
declaration conformity
Declaration of Conformity for Style Edition Purple Rain Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat. III).
declaration conformity
Declaration of Conformity for Style Nitrile Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat. III).
declaration conformity
Declaration of Conformity for ART|ONE FACEMASKS (Type IIR) issued by Akzenta International SA, confirming compliance with EU MDR 2017/745 and relevant harmonized standards.
declaration conformity
Declaration of Conformity for Akzenta International SA sterilization reels and pouches, confirming compliance with EU Medical Device Regulation 2017/745 for Class I medical devices.
declaration conformity
Declaration of Conformity for SMART|ONE ESSENTIAL FACEMASKS, confirming compliance with EU Medical Device Regulation 2017/745 and relevant harmonized standards for Class I medical devices.
declaration conformity
Declaration of Conformity for Akzenta Art|One Extra Care White Latex Gloves, confirming compliance with EU Medical Device Regulation 2017/745 (Class I) and PPE Regulation 2016/425 (Cat III).
declaration conformity
EU Declaration of Conformity for Latex Gloves: Extra Sensitive (Article numbers GLO EL53-AKZ-WH-XS1, S01, M01, LL1) under Regulation (EU) 2016/425, issued by Akzenta International SA.
ifu
Instructions for use for phosphor plate barriers, designed to protect digital imaging plates. Features a tear-off opening for easy removal and soft vinyl corners for patient comfort.