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Emdyca

Manufacturer

Medconn

ChinaLegal entities : Beijing Medconn Medical Devices Co.,Ltd., Shanghai Medconn Biotechnology Co.,Ltd., Shanghai Medconn Medical Technology Co.,Ltd.

Markets : Austria · Belgium · Croatia · Denmark · Finland · Germany · Greece · Netherlands · Northern Ireland · Spain · Türkiye · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 2 · class II · latest in 2026 · see on the FDA website

EU representative : Lotus NL B.V. (Netherlands)

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

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CategoryEMDN codeRegistered modelsClassContact
High performance liquid chromatography systems - consumables W0201050285
18 others
– 98/79 EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other W0103010199
7 others
– 98/79 EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - other W02020699
1 other
A IVDR 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 – 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
D-dimer W0103020503 – 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
Devices for samples analyses - other W05039099 A IVDR EUDAMED record Report an error
IVD general use consumables devices - other accessories W0580 A IVDR EUDAMED record Report an error
Various sample processing instruments - other W02069099 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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