HEINE Optotechnik GmbH & Co. KG
医療用双眼ルーペ、診断用光学機器、照明システムを製造するドイツのメーカー。
医療および歯科分野向けの双眼ルーペ、診断用光学機器、照明システムを製造するドイツのメーカーで、米国、英国、日本に輸出されています。
- Type
- Manufacturer
- Location
- Gilching, Germany
- Founded
- 1946
- Website
- heine.com
- Categories
- 医療およびヘルスケア用品, メガネとサングラス
- Markets
- ドイツ, アメリカ合衆国, イギリス, 日本, オーストラリア
Verified facts
- lei-active (green), checked 2026-08-07 GLEIF global LEI register (golden copy)
- web-presence-since (green), checked 2026-08-04 Internet Archive (Wayback)
- domain-registered (green), checked 2026-08-02 Domain registry record
Profiles
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- 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)
- Sunglasses and protective eyewear are personal protective equipment in the EU: CE marking under Regulation (EU) 2016/425 is required. European Commission (PPE)