EU → US Device Access

Sala-Med Ortopédtechnikai és Gyógyászati Segédeszköz Centrum Kft.

HU-MF-000004191 · Hungary · Budapest

Sala-Med Ortopédtechnikai és Gyógyászati Segédeszköz Centrum Kft. is registered in the European database on medical devices as a manufacturer, with 187 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa187

Most frequent device types declared: Sala-Med Elasztikus gumis haskötő (Sebészeti öv), Sala-Med-52 gumiöves egyoldali lágyéksérvkötő, Sala-Med-23 (ágyékfűző), Sala-Med Adaptálható hasi sérvkötő, normál, Sala-Med -17 (medenceszorító öv).

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 EUDAMED187
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.

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