EU → US Device Access

Sunoptic International Ltd

GB-MF-000009257 · United Kingdom · Harrow

Sunoptic International Ltd is registered in the European database on medical devices as a manufacturer, with 1 064 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 064

Most frequent device types declared: Frames Metal Mix, Reader PC fullrim, Reader metal mix, Frames acetate mix fullrim, Reader PC BLF fullrim.

Among these devices, 388 are declared active.

Authorised representative in the Union: BE-AR-000003314.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 064
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.

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