Fresenius SE & Co. KGaA
Grupo global de saúde que fabrica fluidos intravenosos, bombas de infusão, máquinas de diálise e produtos genéricos…
Grupo global de saúde que fabrica fluidos intravenosos, bombas de infusão, máquinas de diálise e produtos genéricos de nutrição clínica.
- Type
- Manufacturer
- Location
- Bad Homburg, Germany
- Founded
- 1912
- Website
- fresenius.com
- Categories
- Suprimentos médicos e de saúde
- Markets
- Alemanha, Estados Unidos, China, Brasil, Índia
Verified facts
- lei-active (green), checked 2026-08-07 GLEIF global LEI register (golden copy)
- domain-registered (green), checked 2026-08-02 Domain registry record
Profiles
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- FDA Registered FDA Establishment Registration
- Good Manufacturing Practice
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)