77 Elektronika Kft.
Produsen diagnosa medis dan elektronik Hongaria.
77 Elektronika memproduksi pengukur glukosa darah, alat analisa urin, perangkat diagnostik, dan elektronik medis di Hongaria. Didirikan pada tahun 1986, perusahaan ini memasok distributor layanan kesehatan, laboratorium, dan pasar ekspor yang diatur di seluruh dunia.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Budapest, Hungary
- Founded
- 1986
- Website
- e77.hu
- Categories
- Perlengkapan Medis & Kesehatan, Elektronik Konsumen
- Markets
- Hungaria, Jerman, Amerika Serikat, Tiongkok
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)