EU → US Device Access

Oxipit, UAB

LT-MF-000022304 · Lithuania · Vilnius

Oxipit, UAB is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb4
Class IIa1

Most frequent device types declared: ChestEye, MSK Eye, CT Eye, ChestLink.

Among these devices, 5 are declared 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 EUDAMED5
Country of registrationLithuania
⚠️ 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
HZ 1550682-1supplemented2027-02-22
HZ 1550682-1issued2025-12-22

Other manufacturers in Lithuania

All Lithuania manufacturers →