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Emdyca

Manufacturer

SD Biosensor

India, South KoreaLegal entities : SD Biosensor Healthcare Pvt. Ltd., SD Biosensor Inc.

First countries of placing on the market declared in EUDAMED : Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

Website

27 categories, 41 models including 40 on the market, 2 countries

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CategoryEMDN codeRegistered modelsClassContact
Chemistry analysers - software accessories W0201010182 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - consumables W0201020185 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h) W0201020102 A IVDR EUDAMED record Report an error
Bacteriology controls - inf.imm. W0105080801 B, C IVDR EUDAMED record Report an error
Bacteriology - NA reagents - other W0105011699 C IVDR EUDAMED record Report an error
Buffers (unassignable ), supplem. reagents, etc W0105900201 A IVDR EUDAMED record Report an error
C.difficile by NA reagents W0105011804 B IVDR, 98/79 EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC W0105090501 B, C IVDR EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099 A IVDR EUDAMED record Report an error
Blood glucose meters W0201060102 – 98/79 EUDAMED record Report an error
Controls - inf. immunology - other W0105080899 C IVDR EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 – 98/79 EUDAMED record Report an error
H. pylori antigen detection W0105010401 B IVDR EUDAMED record Report an error
HCV antibody -RT & POC W0105090202 D IVDR EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 – 98/79 EUDAMED record Report an error
IVD general use consumables devices - other accessories W0580 A IVDR EUDAMED record Report an error
Legionella antigen detection W0105010501 C IVDR EUDAMED record Report an error
Multiple viruses - multiplex assays - other W0105070399 C IVDR EUDAMED record Report an error
Mycobacteria reagents - other W0105010799 C IVDR EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 C IVDR EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116 A IVDR EUDAMED record Report an error
Other virus combinations - multiplex NA reagents W0105070302 B IVDR EUDAMED record Report an error
Screening high-risk HPV - NA reagents W0105041002 C IVDR EUDAMED record Report an error
Staphylococcal detection by NA reagents W0105011203 C IVDR EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents W0105070501 C IVDR EUDAMED record Report an error
Various sample processing instruments - other W02069099 A IVDR EUDAMED record Report an error
Plasmodium (malaria) - RT & POC No model still on the market W0105090401 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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