EU → US Device Access

Optos plc

GB-MF-000019460 · United Kingdom · Dunfermline

Optos plc is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa9

Most frequent device types declared: P200T, P200TE, P200MA, P200DTx, P200C.

Among these devices, 7 are declared active, 2 with a measuring function.

Authorised representative in the Union: NL-AR-000000116.

United States market access

FDA establishment registerRegistered with FDA
Matched entryOPTOS PLC (GB) · FDA 9617167
Devices in EUDAMED9
Country of registrationUnited Kingdom

Notified body certificates

CertificateStatusExpiry
HZ 1552432-1issued2026-09-27

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