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Emdyca

Manufacturer

Sansure

ChinaLegal entities : Sansure Biotech Inc.

First countries of placing on the market declared in EUDAMED : Belgium, Bulgaria, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Poland, Portugal, Romania, Spain

EU representative : Obelis s.a. (Belgium)

Website info@sansure.com.cn

100 categories, 282 models including 250 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101
24 others
 A IVDR EUDAMED record Report an error
Virology - NA reagents - other W0105040599
12 others
 – 98/79 EUDAMED record Report an error
Enterovirus - NA reagents W0105040502
7 others
 – 98/79 EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus W0105900102
6 others
 – 98/79 EUDAMED record Report an error
Avian influenza - NA reagents W0105040515
2 others
 – 98/79 EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116
2 others
 A IVDR EUDAMED record Report an error
Various sample processing instruments - other W02069099
2 others
 A IVDR EUDAMED record Report an error
Influenza & para influenza - NA reagents W0105040504
2 others
 – 98/79 EUDAMED record Report an error
Adenovirus - NA reagents W0105040501
1 other
 – 98/79 EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents W0105070503
1 other
 C IVDR, 98/79 EUDAMED record Report an error
Bacteriology - NA reagents - other W0105011699
2 others
 – 98/79 EUDAMED record Report an error
H. pylori reagents - other W0105010499 – 98/79 EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents W0105070505 – 98/79 EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003 C IVDR, 98/79 EUDAMED record Report an error
Enterovirus W0105040602 – 98/79 EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504 – 98/79 EUDAMED record Report an error
Other virus combinations - multiplex NA reagents W0105070302 – 98/79 EUDAMED record Report an error
Infectious immunology - other W0105900299 A IVDR, 98/79 EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents W0105011607 – 98/79 EUDAMED record Report an error
Screening high-risk HPV - NA reagents W0105041002 – 98/79 EUDAMED record Report an error
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents W0105070202 – 98/79 EUDAMED record Report an error
Campylobacter detection by NA reagents W0105011402 – 98/79 EUDAMED record Report an error
Ebv - NA reagents W0105040403 C IVDR, 98/79 EUDAMED record Report an error
Multiple viruses - multiplex assays - other W0105070399 – 98/79 EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 C IVDR, 98/79 EUDAMED record Report an error
Neisseria meningitidis - NA reagents W0105011611 – 98/79 EUDAMED record Report an error
Other interleukins (except for il-6) W01030606 – 98/79 EUDAMED record Report an error
Salmonella detection by NA reagents W0105011003 – 98/79 EUDAMED record Report an error
Various general purpose IVD instruments - IVD medical device software W02079092 – 98/79 EUDAMED record Report an error
Rotavirus - NA reagents W0105040506 – 98/79 EUDAMED record Report an error
Hantavirus / bunyavirus - NA reagents W0105040514 – 98/79 EUDAMED record Report an error
D-dimer W0103020503 – 98/79 EUDAMED record Report an error
E. coli detection by NA reagents W0105011503 – 98/79 EUDAMED record Report an error
H. pylori detection by NA reagents W0105010403 – 98/79 EUDAMED record Report an error
Hepatitis c virus - NA reagents W0105020307 – 98/79 EUDAMED record Report an error
Hsv - NA reagents W0105040311 – 98/79 EUDAMED record Report an error
Influenza & para influenza W0105040604 – 98/79 EUDAMED record Report an error
Interleukins receptors (il-2r,il6r ...) W01030607 – 98/79 EUDAMED record Report an error
Multiple infectious - multiplex assays - other W0105070599 – 98/79 EUDAMED record Report an error
Other HPV - NA reagents W0105041005 – 98/79 EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents W0105070502 – 98/79 EUDAMED record Report an error
Parasitology - other W0105050299 – 98/79 EUDAMED record Report an error
Staphylococcal detection by NA reagents W0105011203 – 98/79 EUDAMED record Report an error
Virology - RT & POC - other W0105099099
2 others
 – 98/79 EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 B IVDR, 98/79 EUDAMED record Report an error
Adenovirus W0105040601 – 98/79 EUDAMED record Report an error
Dengue virus - NA reagents W0105040511 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) W0105050209 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
Bk virus - NA reagents W0105040522 – 98/79 EUDAMED record Report an error
Brucella - NA reagents W0105011601 – 98/79 EUDAMED record Report an error
C.difficile by NA reagents W0105011804 – 98/79 EUDAMED record Report an error
C.difficile toxin a/b detection W0105011802 – 98/79 EUDAMED record Report an error
Chikungunya virus - NA reagents W0105040525 – 98/79 EUDAMED record Report an error
Chlamydia pneumoniae detection by NA reagents W0105010118 – 98/79 EUDAMED record Report an error
Chlamydia trachomatis detection by NA reagents W0105010117 – 98/79 EUDAMED record Report an error
Cmv - NA reagents W0105040205 – 98/79 EUDAMED record Report an error
Cryptosporidium W0105050207 – 98/79 EUDAMED record Report an error
Ebola (filovirus) W0105040627 – 98/79 EUDAMED record Report an error
Entamoeba histolytica W0105050201 – 98/79 EUDAMED record Report an error
Fibrinogen degradation products W0103020502 – 98/79 EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents W0105041004 – 98/79 EUDAMED record Report an error
Giardia lamblia W0105050208 – 98/79 EUDAMED record Report an error
Gonococcal detection by NA reagents W0105010203 – 98/79 EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents W0105070201 C IVDR, 98/79 EUDAMED record Report an error
Haemophilus influenzae W0105011710 – 98/79 EUDAMED record Report an error
Haemophilus influenzae - NA reagents W0105011610 – 98/79 EUDAMED record Report an error
Hepatitis a virus - NA reagents W0105020105 – 98/79 EUDAMED record Report an error
Hepatitis b virus - genotyping - NA reagents W0105020218 – 98/79 EUDAMED record Report an error
Hepatitis b virus - NA reagents W0105020216 – 98/79 EUDAMED record Report an error
Hepatitis e virus - NA reagents W0105020507 – 98/79 EUDAMED record Report an error
HIV 1 - NA reagents W0105030107 – 98/79 EUDAMED record Report an error
HPV reagents - other W0105041099 – 98/79 EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
Jc virus - NA reagents W0105040523 – 98/79 EUDAMED record Report an error
Legionella detection by NA reagents W0105010503 – 98/79 EUDAMED record Report an error
Legionella reagents - other W0105010599 – 98/79 EUDAMED record Report an error
Plasminogen activator-inhibitors W0103020506 – 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) W0105040605 – 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents W0105040505 – 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
Strep. a detection by NA reagents W0105011103 – 98/79 EUDAMED record Report an error
Strep. b detection by NA reagents W0105011104 C IVDR, 98/79 EUDAMED record Report an error
Strep. pneumoniae detection by NA reagents W0105011105 – 98/79 EUDAMED record Report an error
Streptococcal reagents - other W0105011199 – 98/79 EUDAMED record Report an error
Syphilis detection by NA reagents W0105010305 – 98/79 EUDAMED record Report an error
Thrombin-antithrombin III-complex W0103020307 – 98/79 EUDAMED record Report an error
Tropical fever - multiplex NA reagents W0105070506 – 98/79 EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...) W01030603 – 98/79 EUDAMED record Report an error
Varicella zoster - NA reagents W0105040904 – 98/79 EUDAMED record Report an error
Viral antigen/antibody detection - other W0105040699 – 98/79 EUDAMED record Report an error
Virology reagents - other W01050499 – 98/79 EUDAMED record Report an error
West nile virus - NA reagent W0105040526 – 98/79 EUDAMED record Report an error
Yersinia - NA reagents W0105011606 – 98/79 EUDAMED record Report an error
Zika virus - NA reagents W0105040531 – 98/79 EUDAMED record Report an error
Coronavirus ag No model still on the market W0105041101 – 98/79 EUDAMED record Report an error
Mumps / parotitis virus reagents - other No model still on the market W0105040899 – 98/79 EUDAMED record Report an error
Mycoplasma antibody assays No model still on the market W0105010802 – 98/79 EUDAMED record Report an error
Norovirus - NA reagents No model still on the market W0105040516 – 98/79 EUDAMED record Report an error

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