Siemens Healthineers
医療画像、診断、高度な治療機器。
Siemens Healthineers は、エアランゲンの事業所で医療画像、診断、高度な治療機器を製造しています。同社は、上場主要市場全体でヘルスケア システム、研究所、OEM パートナー、または規制対象の輸出顧客に供給しています。
- Type
- Manufacturer
- Location
- Erlangen, Germany
- Founded
- 1847
- Website
- siemens-healthineers.com
- Categories
- 医療およびヘルスケア用品, 産業機械
- Markets
- ドイツ, アメリカ合衆国, 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