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Emdyca

Manufacturer

Wiener Laboratorios SAIC

Argentina

Markets : Italy · Netherlands · Romania · Spain · Türkiye · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class I, II · latest in 2009 · see on the FDA website

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

Website marketing@wiener-lab.com

24 categories, 40 models including 19 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Control plasma for haemostasis W0103020702
1 other
 – 98/79 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
Chagas W0105050202 – 98/79 EUDAMED record Report an error
Fibrinogen assays (factor i) W0103020201 – 98/79 EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time W0103020103 – 98/79 EUDAMED record Report an error
Calibration plasma for haemostasis W0103020701 – 98/79 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
Ebv antibodies - other W010504040199 – 98/79 EUDAMED record Report an error
Erythrocyte sedimentation rate devices W02029001 A IVDR EUDAMED record Report an error
Parasites - RT & POC - other W0105090499 – 98/79 EUDAMED record Report an error
Syphilis reagents other W0105010399 – 98/79 EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) No model still on the market W0103010105 A IVDR EUDAMED record Report an error
Antithrombin No model still on the market W0103020602 – 98/79 EUDAMED record Report an error
Auxiliary reagents (haemostasis) - other No model still on the market W0103020999 A IVDR EUDAMED record Report an error
Buffers (haemostasis) No model still on the market W0103020903 A IVDR EUDAMED record Report an error
Chemistry analysers - low routine (with ise mode test/h <= 400) No model still on the market W0201010105 A IVDR EUDAMED record Report an error
Citrate No model still on the market W0103020902 A IVDR EUDAMED record Report an error
Coagulation factor ix No model still on the market W0103020208 – 98/79 EUDAMED record Report an error
Coagulation factor viii No model still on the market W0103020207 – 98/79 EUDAMED record Report an error
Enhancement media (e.g. bovine albumin, liss, peg) No model still on the market W0103030306 A IVDR EUDAMED record Report an error
Haematology controls - other No model still on the market W0103010599 A IVDR EUDAMED record Report an error
Haematology reagents - other No model still on the market W01030199 A IVDR EUDAMED record Report an error
Protein c No model still on the market W0103020607 – 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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