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Emdyca

Manufacturer

Getein

ChinaLegal entities : Getein Biotech, Inc.

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

Approvals : EU – class A, B, C · United States (FDA) – · class I, II

EU representative : CMC Medical Devices & Drugs SL (Spain)

37 categories, 58 models including 58 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
D-dimer W0103020503 C IVDR, 98/79 EUDAMED record Report an error
Other virology controls - inf.imm. W0105080804 – 98/79 EUDAMED record Report an error
Rubella virus igm W0105040103 – 98/79 EUDAMED record Report an error
Dengue virus W0105040611 – 98/79 EUDAMED record Report an error
Integrated / modular chemistry / immunochemistry instruments - other W02010399 A IVDR EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 B IVDR, 98/79 EUDAMED record Report an error
Other interleukins (except for il-6) W01030606 – 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
H. pylori antigen detection W0105010401 B IVDR, 98/79 EUDAMED record Report an error
Influenza & para influenza W0105040604 B IVDR, 98/79 EUDAMED record Report an error
Syphilis antibody assays total W0105010302 C IVDR, 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - consumables W0201020185 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
Coronavirus ag W0105041101 – 98/79 EUDAMED record Report an error
Cytokines calibrators/controls W01030608 – 98/79 EUDAMED record Report an error
D-dimer - RT & POC W0103020803 – 98/79 EUDAMED record Report an error
Fibrinogen degradation products W0103020502 – 98/79 EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents W0105041004 C IVDR EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504 C IVDR 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
Hsv - NA reagents W0105040311 – 98/79 EUDAMED record Report an error
Hsv 1 igg W0105040306 – 98/79 EUDAMED record Report an error
Hsv 1 igm W0105040307 – 98/79 EUDAMED record Report an error
Hsv 2 igg W0105040309 – 98/79 EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 C IVDR EUDAMED record Report an error
Interleukins receptors (il-2r,il6r ...) W01030607 – 98/79 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
Plasmin - a2 - antiplasmin complex W0103020305 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) W0105050209 – 98/79 EUDAMED record Report an error
Rsv - RT & POC W0105099002 – 98/79 EUDAMED record Report an error
SS-thromboglobulin W0103020405 – 98/79 EUDAMED record Report an error
Tb-igra (interferon-gamma-release assay) W0105010704 C IVDR EUDAMED record Report an error
Thrombin activating fibrinolysis inhibitor W0103020509 – 98/79 EUDAMED record Report an error
Thrombin-antithrombin III-complex W0103020307 – 98/79 EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...) W01030603 – 98/79 EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099 A 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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