77 Elektronika Kft.
Fabricante húngaro de diagnósticos médicos e eletrônicos.
77 A Elektronika fabrica medidores de glicemia, analisadores de urina, dispositivos de diagnóstico e eletrónica médica na Hungria. Fundada em 1986, a empresa fornece distribuidores de cuidados de saúde, laboratórios e mercados de exportação regulamentados em todo o mundo.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Budapest, Hungary
- Founded
- 1986
- Website
- e77.hu
- Categories
- Suprimentos médicos e de saúde, Eletrônicos de consumo
- Markets
- Hungria, Alemanha, Estados Unidos, China
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
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)
- registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record
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)