Siemens Healthineers
Medical imaging, diagnostics and advanced therapy equipment.
Siemens Healthineers manufactures medical imaging, diagnostics and advanced therapy equipment from its Erlangen operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Erlangen, Germany
- Founded
- 1847
- Website
- siemens-healthineers.com
- Categories
- Medical & Healthcare Supplies, Industrial Machinery
- Markets
- Germany, United States, Japan, China
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
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- 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
- aeo-certified (green), checked 2026-08-16 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