Ambu GmbH
Medical Technology · Bad Nauheim
Ambu GmbH is a medical technology company based in Bad Nauheim, Germany.
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Ambu GmbH – Address & Contact
Ambu GmbH Overview
Ambu GmbH is a medical technology company based in Bad Nauheim, Hessen. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
As a medical technology company, Ambu GmbH offers solutions for medical facilities, clinics and practices. All products must meet the requirements of the EU Medical Device Regulation (MDR 2017/745) and bear the CE mark.
About Ambu GmbH
Recognized innovation leader in medical technology
Location & Contact
Ambu GmbH can be reached at the following address: Steinkopfstraße 4, 61231 Bad Nauheim – Phone: 06032925000. For current information and enquiries, please contact the company directly.
More information: Medizintechnik in Hessen or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Since May 2021, medical technology companies like Ambu GmbH have had to comply with the EU Medical Devices Regulation (MDR 2017/745), which sets significantly stricter requirements for clinical assessments, traceability and post-market surveillance than the previous directive. All medical devices require CE marking by a notified body and must be registered in the European database EUDAMED.
Branche & Marktumfeld
The German medical technology industry is one of the most innovative industries with over 250,000 employees and a turnover of around 38 billion euros. Ambu GmbH in Bad Nauheim is part of this ecosystem. Germany is the third largest medical technology market in the world after the USA and China. Over 90 percent of the approximately 1,500 medical technology companies are small and medium-sized companies (SMEs), which are often leaders in specialized niches.
Qualitätsmanagement & Zertifizierung
A quality management system in accordance with ISO 13485 is standard practice in the industry for the production and sale of medical devices. The standard defines requirements for the development, production, installation and maintenance of medical devices. In addition, the MDR requires extensive technical documentation, clinical assessments and systematic risk management according to ISO 14971 over the entire product life cycle.
Frequently asked questions about Ambu GmbH
What does Ambu GmbH do?
Hersteller von Einweg-Medizinprodukten für Anästhesie, Visualisierung und Notfallmedizin. Pionier der Einweg-Endoskopie.
Where is Ambu GmbH located?
Ambu GmbH hat seinen Sitz in Bad Nauheim. Kontaktdaten finden Sie auf dieser Seite.
In which field does Ambu GmbH operate?
Ambu GmbH ist in der Medizintechnik-Branche tätig.
What is the EU Medical Device Regulation (MDR)?
Die MDR (Medical Device Regulation, EU 2017/745) ist seit Mai 2021 die maßgebliche Verordnung für Medizinprodukte in der EU. Sie ersetzt die frühere Richtlinie 93/42/EWG und stellt strengere Anforderungen an klinische Bewertungen, Post-Market-Surveillance und Rückverfolgbarkeit. Unternehmen wie Ambu GmbH müssen die MDR-Konformität für alle Produkte nachweisen.
What does the CE marking mean for medical devices?
The CE marking confirms that a medical device meets the requirements of the EU Medical Device Regulation. For products in risk classes Is, Im, Ir, IIa, IIb and III, the involvement of a Notified Body is required to carry out the conformity assessment.
What risk classes exist for medical devices?
Medizinprodukte werden in vier Risikoklassen eingeteilt: Klasse I (geringes Risiko, z.B. Verbandmaterial), Klasse IIa (mittleres Risiko, z.B. Hörgeräte), Klasse IIb (erhöhtes Risiko, z.B. Infusionspumpen) und Klasse III (hohes Risiko, z.B. Herzschrittmacher). Die Klassifizierung bestimmt den Umfang der Konformitätsbewertung.
Medical Technology in Germany
Related areas in healthcare
Medical Technology in Hessen
All Medical Technology in Hessen on Sanoliste — or discover all categories by federal state.