Siemens Healthineers
Équipements d’imagerie médicale, de diagnostic et de thérapie avancée.
Siemens Healthineers fabrique des équipements d'imagerie médicale, de diagnostic et de thérapie avancée à partir de ses opérations d'Erlangen. La société fournit des systèmes de santé, des laboratoires, des partenaires OEM ou des clients exportateurs réglementés sur ses principaux marchés cotés.
- Type
- brand seeking distribution
- Location
- Erlangen, Germany
- Founded
- 1847
- Website
- siemens-healthineers.com
- Categories
- Fournitures médicales et de santé, Machines industrielles
- Markets
- Allemagne, États-Unis, Japon, Chine
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- sanctions-clear (green), checked 2026-08-15 OpenSanctions
- debarment-clear (green), checked 2026-08-15 OpenSanctions
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
- aeo-certified (green), checked 2026-08-30 EU AEO register (European Commission)
Profiles
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
- AEO, Authorised Economic Operator EU AEO database
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)
- No public registry exists for certificates of this kind in this sector: conformity is declared by the manufacturer. European Commission: CE marking, manufacturer's conformity assessment