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Emdyca

Manufacturer

Dirui

ChinaLegal entities : DIRUI INDUSTRIAL CO., LTD

First countries of placing on the market declared in EUDAMED : Austria, Bulgaria, Croatia, Germany, Greece, Italy, Poland, Romania, Spain

EU representative : SUNGO Europe B.V. (Netherlands)

42 categories, 153 models including 153 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) W0103010105
11 others
 A IVDR EUDAMED record Report an error
Haematology controls - other W0103010599
6 others
 – 98/79 EUDAMED record Report an error
D-dimer W0103020503
5 others
 C IVDR, 98/79 EUDAMED record Report an error
Prothrombin time ( quick test ) W0103020101
5 others
 C IVDR, 98/79 EUDAMED record Report an error
Automated urine analysers W020101020103
4 others
 – 98/79 EUDAMED record Report an error
Fibrinogen assays (factor i) W0103020201
3 others
 C IVDR, 98/79 EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101
2 others
 – 98/79 EUDAMED record Report an error
Chemistry analysers - low routine (with ise mode test/h <= 400) W0201010105
1 other
 – 98/79 EUDAMED record Report an error
Control plasma for haemostasis W0103020702
1 other
 C IVDR, 98/79 EUDAMED record Report an error
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr) W0202010102 – 98/79 EUDAMED record Report an error
Fibrinogen degradation products W0103020502 C IVDR, 98/79 EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time W0103020103 C IVDR, 98/79 EUDAMED record Report an error
Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200) W0201010107 B IVDR, 98/79 EUDAMED record Report an error
Urinary sediment devices W0201010202 – 98/79 EUDAMED record Report an error
Antithrombin W0103020602 C IVDR, 98/79 EUDAMED record Report an error
Chemistry analysers - moderate routine (with ise mode test/h > 400 and <= 800) W0201010106 – 98/79 EUDAMED record Report an error
Haemostasis standards and calibrators RT & POC W010302080502 C IVDR, 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
Mixed panel multiparameter analysers - high routine (throughput > 2000 test/h) W0201030103 – 98/79 EUDAMED record Report an error
Reticulocyte controls W0103010506 – 98/79 EUDAMED record Report an error
Syphilis antibody assays total W0105010302 – 98/79 EUDAMED record Report an error
Activated partial thromboplastin time W0103020102 – 98/79 EUDAMED record Report an error
Chemistry analysers - high routine (with ise mode test/h > 1.200) W0201010108 – 98/79 EUDAMED record Report an error
Cytochemical staining reagents W01030702 A IVDR EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other W0103010199 A IVDR, 98/79 EUDAMED record Report an error
Whole blood calibrators W0103010507 – 98/79 EUDAMED record Report an error
Automated coagulometers W0202020102 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - high routine (throughput > 700 test/h) W0201020104 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
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h) W0201020103 A IVDR EUDAMED record Report an error
Automated slide stainers W0202059002 A IVDR EUDAMED record Report an error
Automated systems for the management of pre and post-analysis W02060101 A IVDR EUDAMED record Report an error
Auxiliary reagents (haemostasis) - other W0103020999 A IVDR EUDAMED record Report an error
Buffers (haemostasis) W0103020903 A IVDR EUDAMED record Report an error
Calibration plasma for haemostasis W0103020701 – 98/79 EUDAMED record Report an error
Chemistry analysers - high routine (random access without ise mode test/h > 1.200) W0201010104 – 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
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800) W0201010102 A IVDR EUDAMED record Report an error
Hsv 1+2 igm W0105040304 – 98/79 EUDAMED record Report an error
Hsv 2 igg W0105040309 – 98/79 EUDAMED record Report an error
Semi-automated urine analysers W020101020102 A IVDR EUDAMED record Report an error
Thrombin-antithrombin III-complex W0103020307 – 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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