LUMED is a medical device company specializing in cardiopulmonary diagnostics.
Its origins date back to the early 1990s, when it began manufacturing thermal paper rolls for sports betting, an activity authorized and carried out under the direct supervision of the Italian National Olympic Committee (CONI) and the then Ministry of Finance.
We acquired LUMED in 2000 and, drawing on our more than twenty years of experience in the medical device industry, set out to leverage its expertise while expanding its business into additional industrial and medical applications of thermal paper. As a result, LUMED became one of the first manufacturers to obtain CE certification for thermal paper as a Class I Medical Device with a Measuring Function, in compliance with the European Medical Devices Directive 93/42/EEC (MDD).
This marked the beginning of LUMED’s journey into the world of medical devices. Over the years, LUMED has established a unique position in both the Italian and international markets, becoming a trusted reference for consumables, equipment, and accessories used daily in electrocardiography and pulmonary function testing.
Quality and safety
In the world of manufacturing, obstacles and challenges have always been part of the journey. Our main goal is to improve medical devices, both in their functionality and in every detail. We strive to ensure the highest level of safety for patients and users by thoroughly analysing the potential risks that even well-established, widely used devices may present.
We operate in full compliance with the regulations governing medical devices, as outlined by the Italian Ministry of Health.
Responsabilità ambientale
Today, it is essential to act responsibly toward the environment and the community. Despite new individualistic trends, we must do everything possible to reduce energy consumption, limit plastic use, and create working conditions that foster employee achievement.
By operating under these principles, LUMED has consistently achieved impressive results in international markets.
Radici italiane, connessioni globali
From a company with limited local presence, LUMED now exports to over 60 countries, holds international patents, and has retained customers, some of whom have partnered with us for nearly 25 years.
We have no intention of stopping here. We have launched a series of design, regulatory, and manufacturing initiatives that will lead to the development of new medical devices, increasingly tailored to the needs of our long-standing customers, while enabling us to expand into new target markets.
Innovazione e inclusione
Recently, LUMED attained Innovative SME status, which necessitates ongoing commitment. We have also secured new and essential certifications for our products (EU Regulation No. 2017/745 MDR) and our organization. The latest achievement is the Gender Equality Certification, obtained well in advance of the M5C1-13 target set by the Certification System for June 2026.
Our strengths
We combine experience and innovation to deliver safe, reliable, and ethically designed medical devices, creating lasting value for our customers, our people, and the environment.
Safety for patients and operators
We have always manufactured medical devices in full compliance with applicable regulations and certified in accordance with current standards. Ensuring the safety of both patients and healthcare professionals has always been our highest priority.
Innovation
LUMED is an innovative SME with international patents. We invest in research to develop exclusive medical devices such as BOFAP, a unique product on the market designed to improve safety and efficiency in medical devices.
Independence and reliability
For over 25 years, we have been a stable and reliable partner for our clients in more than 60 countries. We grow with them, innovate, and ensure continuity, strengthening long-term trust-based relationships.
Inclusion and equity
We have obtained Gender Equality Certification, promoting an inclusive, fair, and meritocratic work environment. We value every talent and invest in a sustainable corporate culture.
Ethics and transparency
We operate in full compliance with regulations and with the highest ethical commitment. Our Legality Rating certifies reliability, transparency, and responsibility, fundamental values for our global development.
LUMED wants to be a company able to adapt its competitive ability and its processes over time in order to react to the changing conditions of competitiveness and the changing requirements of modern medicine.
LUMED is firmly convinced that growth, the obvious goal of any company, has to be pursued without any sacrifice and compromise as regards respecting and protecting the customer while operating in compliance with legislative provisions.
Our quality policy embraces this simple and concrete concept:
“assess each action in terms of sustainability”
The Risk/Benefit and Cost/Benefit ratios must be clear to our clientèle. Only an “aware” purchase can be defined “sustainable” by LUMED.
LUMED operates by clearly defining tasks and responsibilities, stimulating collaboration and allocating adequate resources for continual improvement of the corporate management system. To this end, the medium- and long-term aims are clearly defined during the systematic company progress review activities.
LUMED aims at dedicating the necessary attention and the right amount of time to the customer, also at a stage other than purchasing: in that way we want to assess as best we can that we meet the customer’s expectations, considering that only a satisfied customer will remain faithful and bring new customers in.
LUMED is certain that every investment in this direction is the best contribution to achieving stable, long-lasting and sustainable growth objectives.
We therefore focus our efforts on activities that create value for our customers, shareholders, employees, sales partners and other holders involved, making quality and compliance with the essential safety requirements our benchmarks.
La norma armonizzata UNI CEI EN ISO 13485:2016 prevede procedure documentate per identificare i dispositivi medici con mezzi adeguati a partire dal ricevimento e durante tutte le fasi di trattamento fino alla consegna e installazione all’utilizzatore finale. A tale scopo tutti i dispositivi medici fabbricati e/o commercializzati da LUMED srl sono provvisti di un Numero di Lotto presente sulla confezione in modo da consentirne la loro tracciabilità in conformità alla normativa vigente sui dispositivi medici.
The Batch Number is also indicated on the DELIVERY NOTE and the accompanying INVOICE.
It is essential that your internal organization ensure that the information necessary for product traceability towards your customers is maintained in order to allow effective corrective actions in the field in the event of incidents in compliance with the requirements of the medical device standard and MEDDEV 2.12-1 rev.8.
Al fine di agire nel miglior interesse del Cliente, si chiede pertanto di commercializzare i nostri dispositivi medici in modo tale che esista sempre la possibilità di conservare le informazioni necessarie al loro corretto uso, alla loro rintracciabilità e alla loro origine.
Furthermore, LUMED must be notified of any technical or commercial problem relating to the Medical Device as required by the regulations and the laws in force. Should you need further clarification and information, please contact us..
