EU → US Device Access

MEDIN, a.s.

CZ-MF-000012371 · Czechia · Nové Město na Moravě

MEDIN, a.s. is registered in the European database on medical devices as a manufacturer, with 2 342 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb2 221
Class IIa121

Most frequent device types declared: Screw, Nail, Plate.

Among these devices, 776 are declared sterile, 2 221 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 EUDAMED2 342
Country of registrationCzechia
⚠️ 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
2025-MDR/QS-084issued2028-08-31
2024-MDR/TD-058/Asupplemented2029-10-25
2024-MDR/QS-058/Asupplemented2029-10-25
2023-MDR/TD-028/Aissued2028-08-31
2023-MDR/QS-028/Aissued2028-08-31
2023-MDR/QS-028issued2028-08-31

Other manufacturers in Czechia

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