EU → US Device Access

HOSPITAL TECHNICAL SOLUTIONS SRL

RO-MF-000000925 · Romania · BUCURESTI

HOSPITAL TECHNICAL SOLUTIONS SRL is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6
Class IIb5

Most frequent device types declared: HTS-SP3, HTS-EM1, HTS-ER, CPUA, STGM-O2.

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 EUDAMED11
Country of registrationRomania
⚠️ 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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