77 Elektronika Kft.
Венгерский производитель медицинской диагностики и электроники.
77 Elektronika производит в Венгрии глюкометры, анализаторы мочи, диагностические устройства и медицинскую электронику. Основанная в 1986 году, компания поставляет продукцию дистрибьюторам медицинских услуг, лабораториям и регулируемым экспортным рынкам по всему миру.
- Type
- brand seeking distribution
- Location
- Budapest, Hungary
- Founded
- 1986
- Website
- e77.hu
- Categories
- Медицинские товары и расходники, Бытовая электроника
- Markets
- Венгрия, Германия, Соединенные Штаты, Китай
Verified facts
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)