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Emdyca

Manufacturer

Instrumentation Laboratory

United StatesLegal entities : Instrumentation Laboratory Company

Markets : Austria · Italy · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 377 · PMA : 1 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : Italy 36

EU representative : Instrumentation Laboratory SpA (Italy)

Website Regulatory@werfen.com

37 categories, 278 models including 278 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Coagulometers - hardware accessories W0202020180
138 others
A IVDR EUDAMED record Report an error
Coagulometers - consumables W0202020185
23 others
A IVDR EUDAMED record Report an error
Control plasma for haemostasis W0103020702
18 others
B, C IVDR EUDAMED record Report an error
Automated coagulometers W0202020102
11 others
A IVDR EUDAMED record Report an error
Calibration plasma for haemostasis W0103020701
1 other
C 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
D-dimer W0103020503 C IVDR EUDAMED record Report an error
Antithrombin W0103020602 B IVDR EUDAMED record Report an error
Fibrinogen assays (factor i) W0103020201 B IVDR EUDAMED record Report an error
Prothrombin time ( quick test ) W0103020101 C IVDR EUDAMED record Report an error
Activated partial thromboplastin time W0103020102 C IVDR EUDAMED record Report an error
Blood gas analysers - hardware accessories W0201040180 A IVDR EUDAMED record Report an error
Lupus anticoagulant W0103020606 B IVDR EUDAMED record Report an error
Protein c W0103020607 A, B IVDR EUDAMED record Report an error
Coagulation factor ix W0103020208 C IVDR EUDAMED record Report an error
Coagulation factor viii W0103020207 C IVDR EUDAMED record Report an error
Coagulation factor von willebrand (ag) W0103020215 B IVDR EUDAMED record Report an error
Coagulation factor von willebrand activity / ristocetin cofactor activity (rco) W0103020217 B IVDR EUDAMED record Report an error
Platelet factor 4 W0103020402 B IVDR EUDAMED record Report an error
A2-antiplasmin W0103020501 B IVDR EUDAMED record Report an error
Adamts13 (activity, ag, ab, inhibitor) specific von willebrand factor (vwf) - cleaving protease W0103020311 B IVDR EUDAMED record Report an error
Anti iia activity fot doac W0103020310 C IVDR EUDAMED record Report an error
Anti xa activity for heparin and doac W0103020309 C IVDR EUDAMED record Report an error
Apc resistance W0103020610 B IVDR EUDAMED record Report an error
Coagulation factor II ( prothrombin ) W0103020202 B IVDR EUDAMED record Report an error
Coagulation factor v W0103020204 B IVDR EUDAMED record Report an error
Coagulation factor vii W0103020205 B IVDR EUDAMED record Report an error
Coagulation factor X W0103020209 B IVDR EUDAMED record Report an error
Coagulation factor xi W0103020210 B IVDR EUDAMED record Report an error
Coagulation factor xii W0103020211 B IVDR EUDAMED record Report an error
Coagulation factor xiii W0103020213 B IVDR EUDAMED record Report an error
Free protein s antigen W0103020612 B IVDR EUDAMED record Report an error
Homocysteine W0103020614 B IVDR EUDAMED record Report an error
Plasminogen W0103020505 B IVDR EUDAMED record Report an error
Protein s activity W0103020608 B IVDR EUDAMED record Report an error
Standard heparin W0103020303 C IVDR EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time W0103020103 C 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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