INFAI GmbH
Medical Technology · Köln
INFAI GmbH is a medical technology company based in Köln, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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INFAI GmbH Address & Contact
INFAI GmbH Overview
INFAI GmbH, founded in 2002, is based in Cologne, North Rhine-Westphalia, and is an innovative company in the field of medical breath gas analytics and diagnostics. With a clear vision, INFAI aims to revolutionize the diagnosis of metabolic diseases through state-of-the-art technologies and scientific research. The company is particularly known for its 13C breath test, which serves as a non-invasive method for diagnosing Helicobacter pylori as well as a variety of other metabolic diseases. By employing this technology, INFAI has made a significant contribution to improving patient care in Germany while also setting international standards in the field of breath gas diagnostics.
Services and Products
INFAI develops, produces, and markets leading 13C breath tests that are applied in gastroenterological diagnostics. The core of the product portfolio is the Helicobacter breath test (HeliCap), a test that avoids invasive procedures such as endoscopies but still reliably enables the diagnosis of H. pylori infections. This technology is particularly beneficial for patients as it is not only painless but also allows for quick and straightforward execution. Additionally, INFAI has expanded its product line with tests for other conditions, such as lactose intolerance and fructose malabsorption.
- Helicobacter pylori breath test (HeliCap): A non-invasive test for diagnosing stomach infections.
- Lactose breath test: Test for identifying lactose intolerance.
- Fructose breath test: Detection of fructose malabsorption.
- Analysis services: Analysis of breath samples for external laboratories.
- Software solutions: Industry networking for breath test laboratories for the efficient management of tests and results.
The high quality standards and user-friendliness of the products have led to INFAI being regarded not only in Germany but also internationally as one of the leading addresses in breath gas analytics. Furthermore, the company is committed to continuously improving and developing its testing methods to meet the changing demands of the market.
Location Cologne / North Rhine-Westphalia
Cologne, as the fourth-largest city in Germany, offers a strategically favorable location for INFAI GmbH. The city is a hub for numerous pharmaceutical companies and life sciences businesses. The presence of significant research institutions, such as the University of Cologne and the University Hospital Cologne, fosters collaborations that support INFAI in quickly integrating current research findings into product development. This enables the company to continue to operate successfully in a dynamic market.
The North Rhine-Westphalia region is not only known for its economic strength but also for its excellent medical infrastructure. INFAI benefits from support through various networks and initiatives that promote the exchange between companies, research institutions, and clinics. This connection strengthens INFAI not only in its operational efficiency but also contributes to the development of innovative solutions in medical diagnostics.
Through this close collaboration with regional stakeholders as well as through its own research and development activities, INFAI has established a significant role in the field of medical breath gas analytics. These engagements support not only the company itself but also contribute to medical care in the region and beyond.
Other medical technology companies: Medical Technology Overview | Laboratories | Pharmaceutical Companies
Frequently asked questions about INFAI GmbH
What does INFAI GmbH do?
INFAI GmbH is a company in the medical technology sector based in Köln. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is INFAI GmbH located?
INFAI GmbH is headquartered in Köln. More information can be found on the company's website.
In which area of medical technology is INFAI GmbH active?
INFAI GmbH is active in the medical technology sector and offers solutions for medical facilities, clinics and practices. You can find the exact areas of focus on the company's website.
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Medical Technology in Germany
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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.