Siemens Healthcare Diagnostics Products GmbH
DE-MF-000005039 · Germany · Marburg
Siemens Healthcare Diagnostics Products GmbH is registered in the European database on medical devices as a manufacturer, with 415 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_27_MAR EB_A_REAG_OVB, IVDR_27_MAR EB_B_KIT_Ber_a2-Antipl, IVDR_27_MAR EB_B_REAG_INN_Free_PS_Ag, IVDR_27_MAR EB_B_REAG_N_AS_C4, IVDR_27_MAR EB_B_REAG_N_AS_a1-aG.
Devices declared under this manufacturer
- Berichrom a2-Antiplasmin
- Coagulation Factor X Deficient Plasma
- Dabigatran Controls
- Dade Data-Fi Abnormal Fibrinogen Control
- Dade Owren's Veronal Buffer
- Dade PFA Collagen/EPI Test Cartridge
- Dade Thrombin Reagent
- INNOVANCE D-Dimer 2.0 CONTROL 3
- INNOVANCE Free PS Ag
- INNOVANCE Rivaroxaban Standards
- N Antiserum to Human C4
- N Antiserum to Human a1-acid Glycoprotein
Showing 12 of 415 declared devices.
Catalogue references include 10445971, 10446289, 10446307, 10873470, 10873836, 10873839.
European nomenclature codes declared: W0103020702, W0103020799, W0103020102, W0103020701, W0103020201, W0103020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Siemens Healthcare Diagnostics Products GmbH (DE) · FDA 9610806 |
| Devices in EUDAMED | 415 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 415 |
|---|---|
| Found in the U.S. device database | 202 |
| Share | 48.7 % |
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 GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1512506-1 | supplemented | 2026-07-28 |
HX 1512506-1 | reissued | 2031-07-28 |