EU → US Device Access

77 Elektronika Műszeripari Kft

HU-MF-000004266 · Hungary · Budapest

77 Elektronika Műszeripari Kft is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

other36

Most frequent device types declared: UriSed Cuvettes, DocUReader 2 Pro, SmartTester, LabUReader Plus 2.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entry77 ELEKTRONIKA KFT. (HU) · FDA 1000369487
Devices in EUDAMED36
Country of registrationHungary
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
IX 1006099-2issued2031-02-11
IX 1006099-1issued2031-02-11
HX 1006099-1issued2031-02-11

Other manufacturers in Hungary

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