EU → US Device Access

Prima Medical Ltd

UK-MF-000045180 · United Kingdom · Stonehouse

Prima Medical Ltd 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 IIb7
Class IIa4

Among these devices, 7 are declared sterile, 9 active.

Authorised representative in the Union: BE-AR-000000106.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 →