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Manufacturer

Siemens Healthcare Diagnostics

United StatesLegal entities : Siemens Healthcare Diagnostics Inc.

Markets : Austria · Belgium · Germany · United States

Approvals : EU – class A, B, C, D · United States (FDA) – 510(k) : 246 · PMA : 19 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : Austria 72

EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)

Website contact@siemens-healthineers.com

62 categories, 202 models including 202 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Chemistry analysers - consumables W0201010185
32 others
 A IVDR EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) W0103010105
15 others
 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - consumables W0201020185
9 others
 A IVDR EUDAMED record Report an error
Hepatitis virus controls - inf.imm. W0105080802
2 others
 B, D IVDR EUDAMED record Report an error
Blood gas analysers - consumables W0201040185
1 other
 A IVDR EUDAMED record Report an error
Haematology controls - other W0103010599
1 other
 B IVDR, 98/79 EUDAMED record Report an error
Other virology controls - inf.imm. W0105080804
1 other
 C IVDR EUDAMED record Report an error
Chemistry analysers - hardware accessories W0201010180 A IVDR EUDAMED record Report an error
Abnormal blood controls W0103010502 B IVDR, 98/79 EUDAMED record Report an error
Chemistry analysers - low routine (with ise mode test/h <= 400) W0201010105 A IVDR EUDAMED record Report an error
Controls - inf. immunology - other W0105080899 – 98/79 EUDAMED record Report an error
Reticulocyte controls W0103010506 B IVDR, 98/79 EUDAMED record Report an error
Romanowsky stains W0103010302 A IVDR EUDAMED record Report an error
Whole blood calibrators W0103010507 B IVDR, 98/79 EUDAMED record Report an error
Zika virus - NA reagents W0105040531 – 98/79 EUDAMED record Report an error
Automated urine analysers W020101020103 A IVDR EUDAMED record Report an error
Automated urine analysers - consumables W020101020185 A, B IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - hardware accessories W0202010180 A IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr) W0202010102 B IVDR, 98/79 EUDAMED record Report an error
Hepatitis b antigen W0105020211 D IVDR EUDAMED record Report an error
Hepatitis b surface antigen W0105020201 D IVDR EUDAMED record Report an error
Histo / cyto stains W0103010301 A IVDR EUDAMED record Report an error
IVD general use consumable devices - other W0599 A IVDR EUDAMED record Report an error
Normal blood controls W0103010501 B IVDR, 98/79 EUDAMED record Report an error
Various hematology / histology / cytology instruments - hardware accessories W02029080 A IVDR EUDAMED record Report an error
Automated sample transport systems W02060102 A IVDR EUDAMED record Report an error
Bacteriology controls - inf.imm. W0105080801 – 98/79 EUDAMED record Report an error
Cmv igm W0105040204 C IVDR EUDAMED record Report an error
Fixing reagents (histology/cytology) W01030705 A IVDR EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 B IVDR, 98/79 EUDAMED record Report an error
Lymphokines /immunmodulators - other W01030699 B IVDR, 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h) W0201020102 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h) W0201020103 A IVDR EUDAMED record Report an error
Automated slide stainers W0202059002 A IVDR EUDAMED record Report an error
Automated systems for the management of pre and post-analysis W02060101 A IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101 B IVDR EUDAMED record Report an error
Bag sealers W02029010 A IVDR EUDAMED record Report an error
Blood gas analysers - hardware accessories W0201040180 A IVDR EUDAMED record Report an error
BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters) W0201040102 A IVDR EUDAMED record Report an error
Blood gas analysers - with classic profile (pH, PO2, PCO2, hct + electrolytes) W0201040101 A IVDR EUDAMED record Report an error
Cardiac marker portable analysers W0201069001 A IVDR EUDAMED record Report an error
Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200) W0201010107 A IVDR EUDAMED record Report an error
Hav antibody (total) W0105020102 B IVDR EUDAMED record Report an error
Hav antibody igm W0105020104 B IVDR EUDAMED record Report an error
HCV antigen W0105020301 D IVDR EUDAMED record Report an error
Hepatitis b surface antigen - confirmatory W0105020202 D IVDR EUDAMED record Report an error
HIV multiple ag/ab combi test W0105030404 D IVDR EUDAMED record Report an error
Hsv 1 igg W0105040306 C IVDR EUDAMED record Report an error
Hsv 2 igg W0105040309 C IVDR EUDAMED record Report an error
Mixed panel multiparameter analysers - moderate routine (throughput > 800 and <= 2000 test/h) W0201030102 A IVDR EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other W0103010199 B IVDR EUDAMED record Report an error
Retrovirus controls - inf.imm. W0105080803 D IVDR EUDAMED record Report an error
Rubella virus igg W0105040102 C IVDR EUDAMED record Report an error
Rubella virus igm W0105040103 C IVDR EUDAMED record Report an error
Samples analyses, plastic cuvettes W0503010203 A IVDR EUDAMED record Report an error
Semi-automated urine analysers W020101020102 A IVDR EUDAMED record Report an error
Specific reticulocyte reagents W0103010102 A IVDR EUDAMED record Report an error
Syphilis antibody assays total W0105010302 – 98/79 EUDAMED record Report an error
Syphilis antigen detection W0105010301 – 98/79 EUDAMED record Report an error
Toxoplasma antibody igg W0105050102 C IVDR EUDAMED record Report an error
Toxoplasma antibody igm W0105050103 C IVDR EUDAMED record Report an error
Urinary sediment devices W0201010202 B IVDR EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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