EU → US Device Access

Vivostat A/S

DK-MF-000019521 · Denmark · Alleroed

Vivostat A/S is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa14
Class I14

Most frequent device types declared: AZ 220, PRO 800, GM 740, APL 400, VS 323.

Among these devices, 21 are declared sterile, 3 reusable, 4 active.

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 EUDAMED28
Country of registrationDenmark
⚠️ 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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