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Macholdt Inhalatoren GbR – Address & Contact
Macholdt Inhalatoren GbR Overview
Macholdt Inhalatoren GbR is a medical technology company based in Gotha, Thüringen. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Products & Solutions
Macholdt Inhalatoren GbR offers solutions as a medical technology company 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 marking.
Location & Contact
Macholdt Inhalatoren GbR can be reached at the following address: Oberhofer Strasse 3a, 99330 Gotha – Phone: +4903620576234. For current information and enquiries, please contact the company directly.
More information: Medizintechnik in Thüringen or all Medizintechnik in Germany on Sanoliste.
Medizinprodukte-Regulierung (MDR)
Medizintechnikunternehmen wie Macholdt Inhalatoren GbR müssen seit Mai 2021 die EU-Medizinprodukteverordnung (MDR 2017/745) erfüllen, die deutlich strengere Anforderungen an klinische Bewertungen, Rückverfolgbarkeit und Post-Market-Surveillance stellt als die vorherige Richtlinie. Alle Medizinprodukte benötigen eine CE-Kennzeichnung durch eine Benannte Stelle und müssen in der europäischen Datenbank EUDAMED registriert werden.
Branche & Marktumfeld
The deutsche medical technologybranche counts with over 250.000 employeesn and a Umsatz from rund 38 Milliarden Euro zu the innovativsten Industriezweigen. Macholdt Inhalatoren GbR in Gotha is Teil dieses Ökosystems. Germany is after the USA and China the drittgrößte medical technologymarkt worldwide. Über 90 Prozent the rund 1.500 medical technology company are kleine and mittelständische Betriebe (KMU), the häufig in specialiseden Nischen leading sind.
Qualitätsmanagement & Zertifizierung
Für the manufacturing and the distribution from medical devicesn is a quality managementsystem after ISO 13485 branchenüblich. The Norm definiert requirements at development, production, installation and maintenance from medical devicesn. Additionally fordert the MDR umfangreiche technische Dokumentation, clinical Bewertungen and a systematisches Risikomanagement after ISO 14971 over the entire Produktlebenszyklus.
Frequently asked questions about Macholdt Inhalatoren GbR
What does Macholdt Inhalatoren GbR do?
Macholdt Inhalatoren GbR is a company in the medical technology sector based in Gotha. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Macholdt Inhalatoren GbR located?
Macholdt Inhalatoren GbR is headquartered in Gotha. More information can be found on the company's website.
In which area of medical technology is Macholdt Inhalatoren GbR active?
Macholdt Inhalatoren GbR 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.
Medical Technology in Germany
Related areas in healthcare
Medical Technology in Thüringen
All Medical Technology in Thüringen on Sanoliste — or discover all categories by federal state.