HEINE Optotechnik GmbH & Co. KG
Fabricante alemán de lupas binoculares, ópticas de diagnóstico y sistemas de iluminación para el sector médico...
Fabricante alemán de lupas binoculares, ópticas de diagnóstico y sistemas de iluminación para el sector médico y dental, exportando a EE.UU., Gran Bretaña y Japón.
- Type
- brand seeking distribution
- Location
- Gilching, Germany
- Founded
- 1946
- Website
- heine.com
- Categories
- Suministros médicos y sanitarios, Gafas y gafas de sol
- Markets
- Alemania, Estados Unidos, Reino Unido, Japón, Australia
Verified facts
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- 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
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
- 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)