NovoPen® 6 and NovoPen Echo® Plus are CE-marked medical devices. Notified body 0123.
NovoPen® 6 and NovoPen Echo® Plus are certified against the EU Medical Device Directive (MDD) 93/42/EEC.
NovoPen® 6 and NovoPen Echo® Plus are available in a number of countries with additional launches planned in the near future. Timeframes will vary according to device, insulin brand and unique market regulations.
Dose Check is CE marked. Notified body 1282. Dose Check is certified against the EU Medical Device Directive (MDD), 93/42/EEC.
Manufacturer: Amalgam Rx, Inc. 1007 N. Orange St, Ste. 400, Wilmington, DE 19801, USA
Authorized Representative: Medical Device Safety Service GmbH, Schiffgraben 41, 30175 Hannover, Germany.
Dose Check is available in a number of countries and additional launches are planned in the near future. Time frames will vary according to device, insulin brand and unique market regulations.
Dose guidance apps and the information contained in these materials are not intended as a substitute for professional medical advice.
Mallya is an electronic device for the wireless collection and transfer of data of doses administered by an injection pen. Mallya is a regulated healthcare product and carries the CE mark. Mallya is CE marked as a Class 1 medical device in accordance with the EU Medical Device Regulation (MDR), 2017/745.
Legal manufacturer: Biocorp Production – 453 541 054 RCS Clermont-Ferrand – La Bechade ZI La Lavaur, 63500 Issoire, France. Read instructions carefully.
Mallya is available in Japan and additional launches are planned in the near future. Time frames will vary according to device, insulin brand, and unique market regulations.
The information contained on this site is intended for healthcare professionals only outside of the United States of America. This site is not intended to provide medical advice and/or treatment guidance. Only a physician can determine whether a specific product is suitable for a particular patient. This site is not country-specific and therefore may contain information which is not applicable to your country. Novo Nordisk accepts no liability for the accuracy, completeness, or use of this information, and disclaims any liability to update the information contained on this site. By accessing this site and materials you accept this legal notice and expressly confirm your status as a healthcare professional. Any images shown are models and not real patients.
HQ23NPE00010, January 2024