77 Elektronika Kft.
हंगेरियन मेडिकल डायग्नोस्टिक्स और इलेक्ट्रॉनिक्स निर्माता।
77 इलेक्ट्रोनिका हंगरी में रक्त ग्लूकोज मीटर, मूत्र विश्लेषक, नैदानिक उपकरण और चिकित्सा इलेक्ट्रॉनिक्स बनाती है। 1986 में स्थापित, कंपनी दुनिया भर में स्वास्थ्य सेवा वितरकों, प्रयोगशालाओं और विनियमित निर्यात बाजारों को आपूर्ति करती है।
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Budapest, Hungary
- Founded
- 1986
- Website
- e77.hu
- Categories
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ, उपभोक्ता इलेक्ट्रॉनिक्स
- Markets
- हंगरी, जर्मनी, संयुक्त राज्य, चीन
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)