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Emdyca

Manufacturer

BioFynder

United Kingdom (ex Northern Ireland)Legal entities : BioFynder Limited

First countries of placing on the market declared in EUDAMED : Czechia, Finland, France, Germany, Ireland, Italy, Poland, Romania, Spain

EU representative : SUNGO Europe B.V. (Netherlands)

40 categories, 46 models including 46 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Dengue - RT & POC W0105099007 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101 A IVDR EUDAMED record Report an error
Chemistry analysers - low routine (with ise mode test/h <= 400) W0201010105 A IVDR EUDAMED record Report an error
General coagulation tests - other W0103020199 – 98/79 EUDAMED record Report an error
Activated clotting time RT & POC W0103020804 – 98/79 EUDAMED record Report an error
Activated partial thromboplastin time - RT & POC W0103020802 – 98/79 EUDAMED record Report an error
Adenovirus W0105040601 – 98/79 EUDAMED record Report an error
Aspergillus W0105060301 – 98/79 EUDAMED record Report an error
Automated coagulometers W0202020102 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
Candida albicans W0105060302 – 98/79 EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) W0103010105 – 98/79 EUDAMED record Report an error
Coronavirus / influenza - RT & POC W0105090601 – 98/79 EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC W0105090501 – 98/79 EUDAMED record Report an error
Cryptococcus W0105060303 – 98/79 EUDAMED record Report an error
Cytochemical staining reagents W01030702 – 98/79 EUDAMED record Report an error
D-dimer - RT & POC W0103020803 – 98/79 EUDAMED record Report an error
Fibrinogen assays (factor i) W0103020201 – 98/79 EUDAMED record Report an error
Glycosilated hemoglobin devices W0201060101 A IVDR EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex assays W0105070203 – 98/79 EUDAMED record Report an error
H. pylori - RT & POC W0105090102 – 98/79 EUDAMED record Report an error
H. pylori antibody assays W0105010402 – 98/79 EUDAMED record Report an error
H. pylori antigen detection W0105010401 – 98/79 EUDAMED record Report an error
Hemostasis controls RT & POC W010302080501 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004 – 98/79 EUDAMED record Report an error
Ion selective electrolyte analysers W0201040201 A IVDR EUDAMED record Report an error
IVD general use consumable devices - other W0599 A IVDR EUDAMED record Report an error
Mycology immunoassays - other W0105060399 – 98/79 EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents W0105070502 – 98/79 EUDAMED record Report an error
Other multiple pathogens - RT & POC W0105090699 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401 – 98/79 EUDAMED record Report an error
Prothrombin time RT & POC W0103020801 – 98/79 EUDAMED record Report an error
Rotavirus W0105040606 – 98/79 EUDAMED record Report an error
Rsv - RT & POC W0105099002 – 98/79 EUDAMED record Report an error
Strep. a - RT & POC W0105090103 – 98/79 EUDAMED record Report an error
Syphilis - RT & POC W0105090105 – 98/79 EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time W0103020103 – 98/79 EUDAMED record Report an error
Urine strip readers W020101020101 A IVDR EUDAMED record Report an error
Virology - RT & POC - other W0105099099 – 98/79 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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