EU → US Device Access

Alpine HC t/a Opera®

GB-MF-000033029 · United Kingdom · Kingston Upon Hull

Alpine HC t/a Opera® is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa15

Among these devices, 3 are declared active.

Authorised representative in the Union: NL-AR-000006630.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED15
Country of registrationUnited Kingdom
⚠️ 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.

Other manufacturers in United Kingdom

All United Kingdom manufacturers →