EU → US Device Access

Medicontur Medical Engineering Ltd.

HU-MF-000024195 · Hungary · Zsámbék

Medicontur Medical Engineering Ltd. is registered in the European database on medical devices as a manufacturer, with 20 142 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb20 142

Most frequent device types declared: A45RT, 677TAY, 677TA, 677CMTY, 677MTY.

Among these devices, 20 142 are declared sterile, 20 142 implantable.

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 registerNot found in the FDA register
Devices in EUDAMED20 142
Country of registrationHungary
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
2024-MDR/TD-070issued2028-11-10
2024-MDR/QS-070issued2028-11-10
2023-MDR/TD-048/Asupplemented2028-11-10
2023-MDR/TD-047/Aamended2028-11-10
2023-MDR/TD-046/Asupplemented2028-11-10
2023-MDR/QS-048/Asupplemented2028-11-10
2023-MDR/QS-047/Aamended2028-11-10
2023-MDR/QS-046/Asupplemented2028-11-10

Other manufacturers in Hungary

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