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Emdyca

Manufacturer

Jiangsu Macro & Micro-Test Med-Tech

ChinaLegal entities : Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Markets : Germany · Spain · United States

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

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

marketing@hongweitest.com

34 categories, 98 models including 98 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus W0105900102
12 others
 – 98/79 EUDAMED record Report an error
Virology - RT & POC - other W0105099099
11 others
 – 98/79 EUDAMED record Report an error
Viral antigen/antibody detection - other W0105040699
2 others
 – 98/79 EUDAMED record Report an error
Multiple viruses - other W01050799
1 other
 – 98/79 EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003
1 other
 – 98/79 EUDAMED record Report an error
Virology - NA reagents - other W0105040599
1 other
 – 98/79 EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 – 98/79 EUDAMED record Report an error
Mycobacteria reagents - other W0105010799 – 98/79 EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents W0105070503 – 98/79 EUDAMED record Report an error
Dengue virus W0105040611 – 98/79 EUDAMED record Report an error
Multiple viruses - multiplex assays - other W0105070399 – 98/79 EUDAMED record Report an error
Other multiple pathogens - RT & POC W0105090699 C IVDR EUDAMED record Report an error
Bacteriology - NA reagents - other W0105011699 – 98/79 EUDAMED record Report an error
C.difficile toxin a/b detection W0105011802 B IVDR EUDAMED record Report an error
Candida albicans W0105060302 – 98/79 EUDAMED record Report an error
Coronavirus / influenza - RT & POC W0105090601 C IVDR EUDAMED record Report an error
D-dimer W0103020503 – 98/79 EUDAMED record Report an error
Enterovirus - NA reagents W0105040502 – 98/79 EUDAMED record Report an error
H. pylori detection by NA reagents W0105010403 – 98/79 EUDAMED record Report an error
HPV reagents - other W0105041099 – 98/79 EUDAMED record Report an error
Immunochemistry readers W0201020201 A IVDR EUDAMED record Report an error
Influenza & para influenza - NA reagents W0105040504 B IVDR EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
IVD general use consumable devices - other W0599 A IVDR EUDAMED record Report an error
Mycoplasma pneumoniae detection by NA reagents W010501080301 – 98/79 EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other W02050199 A IVDR EUDAMED record Report an error
Other virus combinations - multiplex NA reagents W0105070302 B IVDR EUDAMED record Report an error
Plasmodium (malaria) W0105050209 – 98/79 EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101 A IVDR EUDAMED record Report an error
Samples collection devices - other W05019099 A IVDR EUDAMED record Report an error
Screening high-risk HPV - NA reagents W0105041002 – 98/79 EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents W0105070501 – 98/79 EUDAMED record Report an error
Streptococcal reagents - other W0105011199 – 98/79 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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