Fiagon GmbH
Medical Technology · Oberhavel
Fiagon GmbH is a medical technology company based in Oberhavel, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Fiagon GmbH Address & Contact
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Fiagon GmbH Overview
Fiagon GmbH is an international manufacturer of electromagnetic navigation systems for ENT surgery based in the district of Oberhavel in Brandenburg. The company specializes in the development and production of innovative, image-guided navigation systems, particularly for endoscopic sinus surgery (FESS), otologic surgery, and skull base surgery. With a focus on highly precise technologies, Fiagon GmbH contributes to improving patient safety and surgical outcomes.
Services and Products
The core product of Fiagon is the EMC navigation system, which features electromagnetic tracking. This system allows for precise instrument guidance in ENT surgery and ensures real-time navigation based on CT and MRI imaging with submillimeter accuracy. Fiagon's technology ensures that surgeons can perform precise interventions, minimizing the risk of complications. Furthermore, the EMC navigation system is continuously being developed to meet the latest scientific findings and the needs of surgeons.
- Product Areas: The product portfolio includes not only the EMC navigation system but also software solutions for image processing and special instruments that facilitate integration into existing surgical processes.
- Regulatory Classification: Fiagon's products are classified according to the Medical Devices Regulation MDR 2017/745, thereby meeting all European safety and quality standards.
- Global Application: Fiagon's technologies are used not only in Germany but also in clinics in Europe, North America, and Asia, highlighting the international relevance of the company.
Location Oberhavel / Brandenburg
The district of Oberhavel, located northeast of Berlin, benefits from its strategic proximity to the federal capital, where numerous high-profile university hospitals, such as Charité, are located. This proximity not only creates collaboration opportunities but also access to highly qualified professionals in the field of medical technology. Recently, the region has developed into a significant location for innovative medical technology startups and growth-oriented small and medium-sized enterprises (SMEs).
Oberhavel is characterized by a well-developed infrastructure that promotes exchange between research, industry, and clinics. The region also offers attractive research and development opportunities, which benefit Fiagon GmbH in implementing its innovation strategies. The company also benefits from government funding programs specifically supporting the medical technology industry.
Features of Fiagon GmbH
A remarkable feature of Fiagon GmbH is its interdisciplinary approach, which promotes close collaboration between engineers, physicians, and scientists. This ensures that the developed products are not only technically sophisticated but also tailored to the specific needs of surgeons and patients. User feedback is continuously integrated into the development process, leading to ongoing improvement of products.
Additionally, Fiagon has positioned itself as an innovation leader in medical technology through various awards. Continuous participation in international trade fairs and congresses demonstrates the company's commitment to showcasing its technologies globally and fostering knowledge exchange in the field of medical technology. Partnerships with universities and research institutions further strengthen research and development capacity, leading to innovative solutions in surgery.
Other medical technology companies: Medical Technology Overview | Medical Technology Brandenburg | Laboratories
Frequently asked questions about Fiagon GmbH
What does Fiagon GmbH do?
Über Fiagon GmbH Fiagon GmbH ist ein weltweit führendes Medizintechnikunternehmen, das sich auf die Entwicklung und Herstellung von Navigationssystemen und Instrumenten für die HN
Where is Fiagon GmbH located?
Fiagon GmbH is based in Oberhavel (Brandenburg). Detailed contact information, address and telephone number can be found on this page.
In which field does Fiagon GmbH operate?
Fiagon GmbH operates in the medical technology sector and offers specialised products and services for the German healthcare system.
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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.