Siemens Healthineers
医学成像、诊断和先进治疗设备。
西门子 Healthineers 在埃尔兰根工厂生产医学成像、诊断和先进治疗设备。该公司在其上市主要市场上为医疗保健系统、实验室、OEM 合作伙伴或受监管的出口客户提供服务。
- Type
- Manufacturer
- Location
- Erlangen, Germany
- Founded
- 1847
- Website
- siemens-healthineers.com
- Categories
- 医疗保健用品, 工业机械
- Markets
- 德国, 美国, 日本, 中国
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
- aeo-certified (green), checked 2026-08-07 EU AEO register (European Commission)
Profiles
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission