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
Most frequent device types declared: IVDR_67_LLB_DUB-C_B_REAG_Hackberry Specific Allergen, IVDR_67_LLB_DUB-C_B_REAG_Inhalant Panel 5 Spfc Algn, IVDR_67_LLB_DUB-C_B_REAG_KIT_Free T4, IVDR_67_LLB_DUB-C_B_REAG_KIT_aTPOII, IVDR_67_LLB_DUB-C_C_KIT_Free Beta HCG.
Authorised representative in the Union: Siemens Healthcare Diagnostics Manufacturing Limited.
Devices declared under this manufacturer
- Atellica IM Anti-Thyroglobulin II (aTgII)
- Atellica IM Anti-Thyroid Peroxidase II (aTPOII)
- Atellica IM Placental Growth Factor (PlGF)
- Atellica IM sFlt-1 Quality Control (sFlt-1 QC)
- IMMULITE 2000 AFP
- IMMULITE 2000 European Hornet Specific Allergen
- IMMULITE 2000 Food Panel 51 Specific Allergen
- IMMULITE 2000 Free Beta HCG
- IMMULITE 2000 Free T4
- IMMULITE 2000 HCG Sample Diluent
- IMMULITE 2000 Hackberry Specific Allergen
- IMMULITE 2000 Inhalant Panel 5 Specific Allergen
Showing 12 of 430 declared devices.
Catalogue references include 10368605, 10381298, 10381677, 10385964, 10386095, 11200232.
European nomenclature codes declared: W01020202, W01020203, W0102010114, W0102019099, W01029003, W0102152008.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Siemens Healthcare Diagnostics Products GmbH (DE) · FDA 9610806 |
| Devices in EUDAMED | 430 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 430 |
|---|---|
| Found in the U.S. device database | 165 |
| Share | 38.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
What it holds in Canada
| Licences on record | 19 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 9 |
| Class 3 devices | 3 |
| Class 4 devices | 7 |
| First licensed | 1999-01-26 |
Licence types: Test Kit (9), System (8), Device Family (2).
Licensed under: IMMULITE 2000 SYSTEM (DPC-UK), IMMULITE 1000 SYSTEM (DPC-UK), IMMULITE 1000 SYSTEM (DPC-UK), IMMULITE 2000-2000 XPI INSTRUMENT, IMMULITE 2000 SYSTEM (DPC-UK), IMMULITE CHEMILUMINESCENT SUBSTRATE.
North American profile: Both markets. Siemens Healthcare Diagnostics Products Ltd. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 7091840-1 | supplemented | 2027-01-06 |
HX 7091840-1 | reissued | 2027-03-10 |