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Emdyca

Manufacturer

NanoEntek

South KoreaLegal entities : NanoEntek, Inc.

First countries of placing on the market declared in EUDAMED : Belgium, Czechia, France, Germany, Greece, Hungary, Italy

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

Website eudamed@nanoentek.com

11 categories, 28 models including 28 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Other virology controls - inf.imm. W0105080804 – 98/79 EUDAMED record Report an error
Viral antigen/antibody detection - other W0105040699 – 98/79 EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101 A IVDR EUDAMED record Report an error
Dengue virus W0105040611 – 98/79 EUDAMED record Report an error
Influenza & para influenza W0105040604 – 98/79 EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other W0103010199 – 98/79 EUDAMED record Report an error
Samples analyses, plastic containers - other W050301029099 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
D-dimer W0103020503 – 98/79 EUDAMED record Report an error
Various sample processing instruments - hardware accessories W02069080 A IVDR EUDAMED record Report an error
Virology - NA reagents - other W0105040599 – 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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