77 Elektronika Kft.
ハンガリーの医療診断および電子機器メーカー。
77 Elektronika は、ハンガリーで血糖測定器、尿分析装置、診断装置、医療用電子機器を製造しています。 1986 年に設立された同社は、世界中のヘルスケア販売業者、研究所、規制された輸出市場に製品を供給しています。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Budapest, Hungary
- Founded
- 1986
- Website
- e77.hu
- Categories
- 医療およびヘルスケア用品, 家電
- Markets
- ハンガリー, ドイツ, アメリカ合衆国, 中国
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)