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Emdyca

Manufacturer

Horiba

France, IndiaLegal entities : HORIBA ABX SAS, HORIBA India Pvt. Ltd.

Markets : France · Italy · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 39 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 10 · Italy 1

EU representative : HORIBA ABX SAS (France)

31 categories, 75 models including 74 on the market, 2 countries

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CategoryEMDN codeRegistered modelsClassContact
Complete cell count W0103010103
8 others
 A IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101
7 others
 B IVDR EUDAMED record Report an error
Auxiliary reagents (haemostasis) - other W0103020999 A IVDR EUDAMED record Report an error
Prothrombin time ( quick test ) W0103020101 – 98/79 EUDAMED record Report an error
Activated partial thromboplastin time W0103020102 – 98/79 EUDAMED record Report an error
IVD general use consumables devices - other accessories W0580 A IVDR EUDAMED record Report an error
Multilevel blood controls W0103010503 B IVDR EUDAMED record Report an error
Samples analyses, plastic cuvettes W0503010203 A IVDR EUDAMED record Report an error
Semi-automated coagulometers W0202020101 A IVDR EUDAMED record Report an error
Automated coagulometers W0202020102 A IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr) W0202010102 B IVDR EUDAMED record Report an error
Control plasma for haemostasis W0103020702 C IVDR, 98/79 EUDAMED record Report an error
Fibrinogen assays (factor i) W0103020201 – 98/79 EUDAMED record Report an error
Haematology controls - other W0103010599 B IVDR EUDAMED record Report an error
Antithrombin W0103020602 – 98/79 EUDAMED record Report an error
Automated 3 part hematology analysers W0202010201 – 98/79 EUDAMED record Report an error
Automated sample transport systems W02060102 A IVDR EUDAMED record Report an error
Automated slide stainers W0202059002 A IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - software accessories W0202010182 A IVDR EUDAMED record Report an error
Calcium chloride W0103020901 A IVDR EUDAMED record Report an error
Calibration plasma for haemostasis W0103020701 C IVDR EUDAMED record Report an error
Cell counting instruments - other W02020199 A IVDR EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400) W0201010101 A IVDR EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800) W0201010102 A IVDR EUDAMED record Report an error
D-dimer W0103020503 – 98/79 EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other W0103010199 A IVDR EUDAMED record Report an error
Reticulocyte controls W0103010506 B IVDR EUDAMED record Report an error
Samples analyses, plastic containers - other accessories W0503010280 A IVDR EUDAMED record Report an error
Specific reticulocyte reagents W0103010102 A IVDR EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time W0103020103 – 98/79 EUDAMED record Report an error
Whole blood calibrators W0103010507 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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