LLC Proton
Дистрибьютор медицинского оборудования DACH и Бенилюкса, 12 лет на рынке
ООО «Протон» занимается дистрибуцией медицинских изделий, диагностических наборов, фармацевтической косметической продукции и пищевых добавок в странах DACH, Бенилюкса, Франции и Польши. 14 лет активности, 24 бренда, сертификаты ISO 13485 и GMP.
- Type
- distributor seeking brands
- Location
- Hamburg, Germany
- Founded
- 2012
- Website
- proton-distribution.de
- Categories
- Медицинские товары и расходники, Средства личной гигиены, БАДы и товары для здоровья
- Markets
- Германия, Австрия, Швейцария, Нидерланды, Бельгия, Люксембург
Verified facts
- debarment-clear (green), checked 2026-08-16 OpenSanctions
- sanctions-clear (green), checked 2026-08-16 OpenSanctions
Claimed certifications
- CE Marking EU NANDO (notified bodies)
- ISO 13485, Medical Devices Quality IAF CertSearch
Import rules for these goods
- Food supplements sold in the EU follow Directive 2002/46/EC: most member states require a notification to the national authority before the first sale. European Commission (supplements)
- 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)