HEINE Optotechnik GmbH & Co. KG
German manufacturer of binocular loupes, diagnostic optics and illumination systems for the medic…
German manufacturer of binocular loupes, diagnostic optics and illumination systems for the medical and dental sector, exported to the US, GB and Japan.
- Type
- Manufacturer
- Location
- Gilching, Germany
- Founded
- 1946
- Website
- heine.com
- Categories
- Medical & Healthcare Supplies, Eyewear & Sunglasses
- Markets
- Germany, United States, United Kingdom, Japan, Australia
Verified facts
- 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)
- web-presence-since (green), checked 2026-08-04 Internet Archive (Wayback)
- debarment-clear (green), checked 2026-08-16 OpenSanctions
- sanctions-clear (green), checked 2026-08-16 OpenSanctions
- domain-registered (green), checked 2026-08-02 Domain registry record
- vat-valid (green), checked 2026-08-18 VIES (European Commission)
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)