Edwards Lifesciences
Herzklappen, Überwachung der Intensivpflege und strukturelle Herzprodukte.
Edwards Lifesciences stellt in seinem Betrieb in Irvine Herzklappen, Überwachungsgeräte für die Intensivpflege und strukturelle Herzprodukte her. Das Unternehmen beliefert Gesundheitssysteme, Labore, OEM-Partner oder regulierte Exportkunden in seinen aufgeführten Hauptmärkten.
- Type
- brand seeking distribution
- Location
- Irvine, United States
- Founded
- 1958
- Website
- edwards.com
- Categories
- Medizin- & Gesundheitsbedarf
- Markets
- Vereinigte Staaten, Deutschland, Japan, China
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- facility-registered (green), checked 2026-08-07 US EPA Facility Registry Service (national combined file)
- fda-registered (green), checked 2026-08-08 FDA
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- lei-active (green), checked 2026-08-08 GLEIF
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- FDA Registered FDA Establishment Registration
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)