EU → US Device Access

Immunodiagnostic Systems Limited

GB-MF-000015851 · United Kingdom · Boldon, Tyne & Wear

Immunodiagnostic Systems Limited is registered in the European database on medical devices as a manufacturer, with 208 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other208

Most frequent device types declared: IS-5400, IS-DS200, IS-2500N, IS-4600, IS-3000N.

Authorised representative in the Union: BE-AR-000015342.

United States market access

FDA establishment registerRegistered with FDA
Matched entryIMMUNODIAGNOSTIC SYSTEMS LTD. (GB) · FDA 8021924
Devices in EUDAMED208
Country of registrationUnited Kingdom

Notified body certificates

CertificateStatusExpiry
HX 2333083-1supplemented2028-08-26

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