Celsius42 GmbH
Medical Technology · Aachen
Celsius42 GmbH is a medical technology company based in Aachen, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
Content in German
The detailed company information on this page is provided in the original German language. You can use your browser's built-in translation feature to view it in English.
Right-click on the page and select "Translate to English" or use the translation icon in your browser's address bar.
Celsius42 GmbH Address & Contact
Celsius42 GmbH at a Glance
Celsius42 GmbH is a company based in Aachen, North Rhine-Westphalia, specialized in medical hyperthermia. The company develops therapy devices for regional and localized hyperthermia, which are used as a complement to radiation therapy and chemotherapy in oncological treatment. Celsius42 is a modern medical technology company in the growing field of non-invasive cancer therapy, distinguished by innovative technologies and a scientifically-based approach.
Services and Products
The core product of Celsius42 is a hyperthermia system that specifically heats tumor tissue to therapeutic temperatures using high-frequency waves, in order to increase the sensitivity of tumor cells to radiation or cytostatics. The scientific basis of this form of therapy demonstrates that heating the tumor tissue destabilizes cell membranes, improves circulation, and activates the immune response. The systems are employed in radiation therapy centers and oncology departments of hospitals, with particular emphasis on integration into existing treatment concepts. Additionally, Celsius42 offers clinical support and training for medical staff to ensure the effective and safe use of their technologies.
- Regional Hyperthermia System: Specifically developed for the treatment of larger tumors.
- Local Hyperthermia System: Targets smaller tumor areas and minimizes damage to surrounding tissue.
- Training Programs: Continuing education offerings for doctors and nursing staff for optimal use of the devices.
Regulatory Classification and Approvals
The products of Celsius42 are subject to strict regulation of medical technology in Europe. The devices are designed and approved according to the MDR (Medical Device Regulation). This means that they must not only meet strict testing criteria regarding their safety and efficacy, but are also continuously monitored. Celsius42 is committed to the highest quality standards and has implemented a comprehensive quality management system that ensures traceability of the products. With the CE marking, the company is authorized to market its products in all EU member states.
Regional Importance and Collaborations
Aachen is home to RWTH Aachen University and the University Hospital Aachen, both of which are important partners for medical technology innovations. RWTH Aachen is one of the leading technical universities in Europe and has initiated numerous research projects in the field of medical technology in recent years. These academic institutions promote the development of new technologies and strengthen the knowledge transfer between research and industry. The proximity to the Belgian and Dutch borders makes Aachen a strategic location for the European medical technology market and allows Celsius42 to operate competitively on an international scale. There is an active ecosystem in the region comprising startups, research institutes, and established medical technology companies that fosters the exchange of ideas and innovations.
Special Features of Celsius42 GmbH
Celsius42 distinguishes itself through its focused R&D strategy, which is based on evidence-based medicine and emphasizes the integration of hyperthermia into multimodal cancer treatment. The company closely collaborates with clinics and research institutes to conduct clinical studies to demonstrate the efficacy of its products. The continuous development of their technologies and the pursuit of excellence in customer service are further key factors for the company's success. Celsius42 is not only a provider of medical technology but also an active contributor to the oncological care landscape.
Other medical technology companies in the region: Medical Technology in North Rhine-Westphalia or all Medical Technology in Germany on Sanoliste.
```Frequently asked questions about Celsius42 GmbH
What does Celsius42 GmbH do?
Celsius42 GmbH is a company in the medical technology sector based in Aachen. The company develops, manufactures or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Celsius42 GmbH based?
Celsius42 GmbH is based in Aachen. Detailed information can be found on the company website.
In which area of medical technology does Celsius42 GmbH operate?
Celsius42 GmbH operates in the medical technology sector and offers solutions for healthcare facilities, hospitals and practices. The exact areas of activity can be found on the company website.
More Medical Technology in Aachen
Medical Technology in Germany
Related areas in healthcare
Medical Technology by location
About Medical Technology
Germany's medical technology sector is one of the most important in the world. With annual revenues of approximately EUR 36 billion and more than 1,400 companies, Germany ranks as the third-largest medical technology market globally (SPECTARIS 2023), after the United States and Japan. The sector encompasses the development, manufacture and distribution of an extraordinarily wide range of products: in-vitro diagnostic (IVD) devices, medical imaging systems (CT, MRI, ultrasound), implants such as hip and knee prostheses, cardiac pacemakers, surgical instruments, hospital beds, wound care products and medical software classified as a Software as a Medical Device (SaMD). In Germany and across the European Union, medical devices must comply with the EU Medical Device Regulation (MDR 2017/745), which replaced the former Medical Devices Directive (MDD 93/42/EEC). Devices are classified into risk classes I, IIa, IIb and III. Higher-risk classes require a conformity assessment by a designated Notified Body (benannte Stelle) before a CE mark can be affixed. The CE mark signals that the product meets EU safety, performance and quality requirements and may be placed on the European market. Key medtech clusters in Germany include the Munich and Nuremberg region in Bavaria, the Rhine-Main area in Hesse, Tuttlingen in Baden-Württemberg (known as the world capital of surgical instruments) and the Hamburg metropolitan area. This directory lists CE-certified manufacturers, distributors and suppliers across the German medtech sector with full contact details.
Germany as a Global Medical Technology Hub
Germany's position as the world's third-largest medical technology market is underpinned by a combination of industrial engineering excellence, a well-funded healthcare system and a highly productive research landscape. The German medtech sector is characterised by a large number of small and medium-sized enterprises (SMEs) that are often hidden champions (Weltmarktführer) in specialised niches. Unlike the pharmaceutical sector, where large corporations dominate, the medtech industry is more fragmented and innovative, with frequent spin-offs from university hospitals and engineering faculties. Key product categories include imaging systems (MRI, CT, X-ray, ultrasound), endoscopy and minimally invasive surgical tools, orthopaedic implants, cardiovascular devices, in-vitro diagnostics, dental equipment, ophthalmic devices, wound care systems and hospital IT and medical software. Germany is particularly renowned for its surgical instrument manufacturing, centred in Tuttlingen, Baden-Württemberg, which supplies operating theatres worldwide. The annual Medica trade fair in Düsseldorf is the world's largest medical technology exhibition and serves as a global industry showcase.
EU MDR Compliance and CE Marking for German Manufacturers
The EU Medical Device Regulation (MDR 2017/745) replaced the former Medical Devices Directive (MDD 93/42/EEC) and has applied in full since May 2021, with transition periods for legacy devices extended to 2028 in some cases. For German manufacturers selling in the EU market, MDR compliance is a legal necessity. The regulation introduced significantly strengthened requirements compared to the old MDD: more rigorous clinical evidence requirements, mandatory post-market clinical follow-up (PMCF), unique device identification (UDI) registration in the EUDAMED database, increased obligations for Notified Bodies, and stricter rules for software as a medical device (SaMD). The risk classification system under MDR uses four classes (I, IIa, IIb, III) based on the intended purpose, duration of use and body contact of the device. Manufacturers must appoint an authorised representative in the EU if they are not themselves based in an EU member state, and they must maintain a quality management system. In Germany, the Bundesnetzagentur and state authorities support MDR enforcement alongside BfArM.
Innovation and Research in German Medtech
Germany's medtech innovation ecosystem benefits from close collaboration between industry, university hospitals (Universitätsklinika), applied research institutes (such as those of the Fraunhofer and Helmholtz networks) and health technology assessment bodies. The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) play important roles in assessing which new medical technologies are eligible for reimbursement by statutory health insurance (GKV). This reimbursement pathway, known as the NUB process (Neue Untersuchungs- und Behandlungsmethoden) for hospital technologies, is a key milestone for commercial success in Germany. Innovative devices that receive a positive NUB assessment can be reimbursed at negotiated rates by statutory insurers, providing a significant market access advantage.
Innovation Fields and Future Technologies
The German medical technology sector is driving numerous future fields forward. AI-supported diagnostics and image analysis are revolutionising radiology and pathology; algorithms for the early detection of cancer and cardiovascular disease are increasingly receiving CE approvals as Software as a Medical Device (SaMD). Robot-assisted surgical systems, led by products from Siemens Healthineers, Brainlab and Karl Storz, are improving precision in complex procedures. Minimally invasive technologies, implantable pacemakers and intelligent prostheses with sensory feedback demonstrate the breadth of innovation. Point-of-care diagnostics enables rapid tests directly in the doctor's surgery or at the bedside. Telemedicine and digital patient records promote networking between medical devices and clinical workflows. The Federal Ministry of Education and Research (BMBF) funding programme specifically supports the development of innovative medical technology products through cooperation between industry and universities.
What does the medical technology sector cover?
Medical technology encompasses the development, manufacture and distribution of medical devices, instruments, software and accessories used to diagnose, prevent, monitor or treat diseases. Germany ranks among the world's leading medical technology hubs.
How are medical devices approved in Germany?
Medical devices in Germany and the EU must comply with the EU Medical Device Regulation (MDR 2017/745) and carry the CE mark. Depending on the risk class, conformity assessments by notified bodies are required.
Where can I find medical technology companies in Germany?
Medical technology companies in Germany can be found through industry associations such as SPECTARIS, BVMed or ZVEI, and via the EUDAMED EU database for registered manufacturers. Sanoliste provides a searchable directory of manufacturers, distributors and suppliers across the German medical technology sector.
How many medical technology companies are there in Germany?
Germany has more than 1,400 medical technology companies generating annual revenues of approximately EUR 36 billion (SPECTARIS 2023), making it the third-largest medical technology market in the world. The majority of companies are small and medium-sized enterprises (SMEs), many of which are world market leaders in their niche.
What are the risk classes for medical devices under the EU MDR?
The EU Medical Device Regulation (MDR 2017/745) classifies medical devices into four risk classes: Class I (lowest risk, e.g. bandages, glasses frames), Class IIa (medium risk, e.g. hearing aids, contact lenses), Class IIb (higher medium risk, e.g. infusion pumps, ventilators) and Class III (highest risk, e.g. implantable cardiac devices, neurosurgical instruments). Higher classes require more rigorous conformity assessment by a Notified Body.
Where are the main medical technology clusters in Germany?
Germany's medical technology industry is concentrated in several regional clusters. Bavaria (particularly Munich and Nuremberg) and Baden-Württemberg (notably Tuttlingen, globally known for surgical instruments) are the two strongest regions. Other significant clusters include the Rhine-Main area in Hesse, the Hamburg metropolitan region, the Ruhr area in North Rhine-Westphalia and the Berlin-Brandenburg region.
What is a Notified Body (benannte Stelle) and why does it matter?
A Notified Body (benannte Stelle) is an independent third-party organisation designated by an EU member state to assess whether medical devices meet the requirements of the MDR before they can carry the CE mark. For Class IIa, IIb and III devices, manufacturers must have their quality management system and technical documentation assessed by a Notified Body. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) oversees market surveillance, while several German organisations hold Notified Body status under the MDR.