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Emdyca

Manufacturer

Shenzhen Yhlo Biotech

ChinaLegal entities : SHENZHEN YHLO BIOTECH CO., LTD.

Markets : Cyprus · France · Germany · Greece · Italy · Netherlands · Romania · Spain · United States

Approvals : EU – class A, C · United States (FDA) – 510(k) : 1 · class I, II · latest in 2023 · see on the FDA website

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

Website info@szyhlo.com

41 categories, 71 models including 71 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Other virology controls - inf.imm. W0105080804
9 others
 C IVDR, 98/79 EUDAMED record Report an error
Bacteriology controls - inf.imm. W0105080801
1 other
 C IVDR, 98/79 EUDAMED record Report an error
Erythrocyte sedimentation rate devices W02029001
1 other
 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 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 systems for the management of pre and post-analysis W02060101 A IVDR EUDAMED record Report an error
Ebv antibodies - other W010504040199 C IVDR EUDAMED record Report an error
Mycoplasma antibody assays W0105010802 C IVDR EUDAMED record Report an error
Parasitology controls - inf.imm. W0105080805 C IVDR EUDAMED record Report an error
Chemistry analysers - low routine (with ise mode test/h <= 400) W0201010105 A IVDR EUDAMED record Report an error
Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200) W0201010107 A IVDR EUDAMED record Report an error
Chlamydia pneumoniae antibody igg W0105010115 C IVDR EUDAMED record Report an error
Chlamydia pneumoniae antibody igm W0105010116 C IVDR EUDAMED record Report an error
Cmv igg W0105040203 C IVDR EUDAMED record Report an error
Cmv igm W0105040204 C IVDR EUDAMED record Report an error
Coagulation inhibitors - other W0103020699 C IVDR EUDAMED record Report an error
D-dimer W0103020503 C IVDR EUDAMED record Report an error
Ebv ea igg W010504040108 C IVDR EUDAMED record Report an error
Ebv ea igm W010504040107 C IVDR EUDAMED record Report an error
Ebv ebna igg W010504040106 C IVDR EUDAMED record Report an error
Ebv vca igg W010504040105 C IVDR EUDAMED record Report an error
Ebv vca igm W010504040104 C IVDR EUDAMED record Report an error
Fibrinogen degradation products W0103020502 C IVDR EUDAMED record Report an error
Fibrinolysis tests - other W0103020599 C IVDR EUDAMED record Report an error
Haemostasis controls - other W0103020799 C IVDR EUDAMED record Report an error
Hsv 1 igg W0105040306 C IVDR EUDAMED record Report an error
Hsv 1 igm W0105040307 C IVDR EUDAMED record Report an error
Hsv 2 igg W0105040309 C IVDR EUDAMED record Report an error
Hsv 2 igm W0105040310 C IVDR EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 C IVDR EUDAMED record Report an error
Plasmin - a2 - antiplasmin complex W0103020305 C IVDR EUDAMED record Report an error
Rubella virus igg W0105040102 C IVDR EUDAMED record Report an error
Rubella virus igm W0105040103 C IVDR EUDAMED record Report an error
Samples analyses, plastic cuvettes W0503010203 A IVDR EUDAMED record Report an error
Syphilis antibody assays total W0105010302 C IVDR EUDAMED record Report an error
Thrombin-antithrombin III-complex W0103020307 C IVDR EUDAMED record Report an error
Toxoplasma antibody igg - avidity W0105050104 C IVDR EUDAMED record Report an error
Toxoplasma antibody igm W0105050103 C IVDR EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - hardware accessories W0201069080 A IVDR 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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