Fresenius SE & Co. KGaA
Global healthcare group manufacturing IV fluids, infusion pumps, dialysis machines and generic cl…
Global healthcare group manufacturing IV fluids, infusion pumps, dialysis machines and generic clinical nutrition products.
- Type
- Manufacturer
- Location
- Bad Homburg, Germany
- Founded
- 1912
- Website
- fresenius.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Germany, United States, China, Brazil, India
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- sanctions-clear (green), checked 2026-08-16 OpenSanctions
- debarment-clear (green), checked 2026-08-16 OpenSanctions
- vat-valid (green), checked 2026-08-18 VIES (European Commission)
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)