Fisher & Paykel Healthcare GmbH & Co KG
Medical Technology · Rems-Murr-Kreis
Fisher & Paykel Healthcare GmbH & Co KG is a medical technology company based in Rems-Murr-Kreis, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Fisher & Paykel Healthcare GmbH & Co KG Overview
Fisher & Paykel Healthcare GmbH & Co KG is the German subsidiary of the New Zealand medical technology company Fisher & Paykel Healthcare, which specializes in airway management and ventilation therapy. The German sales office is located in Rems-Murr-Kreis, Baden-Württemberg. Fisher & Paykel Healthcare is one of the leading providers of humidification systems, CPAP masks, and high-flow therapy products worldwide. With a deep understanding of the needs of patients and medical staff, the company develops innovative solutions to improve treatment outcomes and the quality of life for patients.
Services and Products
The product range includes a variety of devices and systems characterized by high quality and user-friendliness. Core products include:
- Ventilator humidifiers: These devices are crucial for optimizing ventilation therapy by increasing air humidity and thus protecting the mucous membranes of the airways.
- High-flow nasal cannula systems (Optiflow): These systems enable effective oxygen supply for patients with breathing difficulties and are indispensable in both clinical and home therapies.
- CPAP masks: Continuous Positive Airway Pressure therapy is a proven method for treating sleep apnea, and Fisher & Paykel Healthcare offers a variety of masks for different needs.
- Intensive care and anesthesia accessories: The company also supplies recognized products specifically designed for use in critical environments to maximize safety and user-friendliness.
Through this product diversity, Fisher & Paykel Healthcare GmbH & Co KG enables the delivery of high-quality therapies in various medical fields, including intensive care units, anesthesia departments, and the home care of patients with respiratory diseases.
Regulatory Classification and Quality Standards
Fisher & Paykel Healthcare GmbH & Co KG is subject to strict regulatory requirements typical for the medical technology industry. All products have the necessary certifications, including the CE mark, which certifies compliance with European health, safety, and environmental protection standards. The company is ISO 13485 certified, ensuring compliance with international standards for quality management systems for medical devices.
Regional Significance
The Rems-Murr-Kreis is located northeast of Stuttgart and borders the state capital. The region provides access to the strong medical technology and pharmaceutical industry of the Stuttgart metropolitan area, as well as the automotive supplier infrastructure of the region. Clinics such as Robert-Bosch-Krankenhaus Stuttgart and Klinikum Stuttgart are potential reference customers nearby. Fisher & Paykel Healthcare benefits from proximity to research institutions and innovation centers located in the region. This connection not only promotes the exchange of knowledge and technologies but also offers opportunities for collaborations and joint development projects.
Highlights and Innovations
Particularly noteworthy is Fisher & Paykel Healthcare's commitment to research and development. Innovative design and the integration of state-of-the-art technology distinguish the products. For example, new humidification technologies have emerged in recent years that significantly enhance patient comfort and improve the efficiency of ventilation therapy. Additionally, the company is committed to sustainability by using environmentally friendly materials and optimizing production processes to minimize the ecological footprint. Continuous feedback from healthcare professionals and patients directly informs future product developments, underscoring the high acceptance and satisfaction of users.
Other medical technology companies in the region: Medical Technology in Baden-Württemberg or all Medical Technology in Germany on Sanoliste.
```Frequently asked questions about Fisher & Paykel Healthcare GmbH & Co KG
What does Fisher & Paykel Healthcare GmbH & Co KG do?
Fisher & Paykel Healthcare GmbH & Co KG is a company in the medical technology sector based in Rems-Murr-Kreis. The company develops, manufactures or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Fisher & Paykel Healthcare GmbH & Co KG based?
Fisher & Paykel Healthcare GmbH & Co KG is based in Rems-Murr-Kreis. Detailed information can be found on the company website.
In which area of medical technology does Fisher & Paykel Healthcare GmbH & Co KG operate?
Fisher & Paykel Healthcare GmbH & Co KG 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.
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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.