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Siemens Healthcare Diagnostics Products Ltd.

GB-MF-000016339 · United Kingdom · Llanberis, Gwynedd

Siemens Healthcare Diagnostics Products Ltd. is registered in the European database on medical devices as a manufacturer, with 430 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other430

Most frequent device types declared: IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII, IVDR_67_LLB_DUB-C_B_KIT_aTgII, IVDR_67_LLB_DUB-C_C_KIT_PBNP, IVDR_67_LLB_DUB-C_C_KIT_Thyroglobulin, IVDR_67_LLB_DUB-C_B_REAG_KIT_Free T4.

Authorised representative in the Union: IE-AR-000006763.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySiemens Healthcare Diagnostics Products GmbH (DE) · FDA 9610806
Devices in EUDAMED430
Country of registrationUnited Kingdom

Notified body certificates

CertificateStatusExpiry
HX 7091840-1supplemented2027-01-06
HX 7091840-1reissued2027-03-10

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