77 Elektronika Kft.
Hungarian medical diagnostics and electronics manufacturer.
77 Elektronika manufactures blood glucose meters, urine analyzers, diagnostic devices, and medical electronics in Hungary. Founded in 1986, the company supplies healthcare distributors, laboratories, and regulated export markets worldwide.
- Type
- Manufacturer
- Location
- Budapest, Hungary
- Founded
- 1986
- Website
- e77.hu
- Categories
- Medical & Healthcare Supplies, Consumer Electronics
- Markets
- Hungary, Germany, United States, China
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)