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Emdyca

Manufacturer

HangZhou Biotest  Biotech

ChinaLegal entities : HangZhou Biotest  Biotech Co.,Ltd.

Markets : Cyprus · Germany · Ireland · Northern Ireland · Spain · United States

Approvals : EU – class A, B, C · United States (FDA) – · class I, II

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

info@biotests.com.cn

57 categories, 107 models including 107 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Virology - RT & POC - other W0105099099
4 others
 – 98/79 EUDAMED record Report an error
Other multiple pathogens - RT & POC W0105090699
3 others
 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401
3 others
 – 98/79 EUDAMED record Report an error
Bacteriology - RT & POC - other W0105090199 – 98/79 EUDAMED record Report an error
Cmv reagents - other W0105040299 – 98/79 EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC W0105090501 – 98/79 EUDAMED record Report an error
H. pylori - RT & POC W0105090102 B IVDR, 98/79 EUDAMED record Report an error
Hepatitis viruses - RT & POC - other W0105090299 – 98/79 EUDAMED record Report an error
Rsv - RT & POC W0105099002 – 98/79 EUDAMED record Report an error
Strep. a - RT & POC W0105090103 B, C IVDR, 98/79 EUDAMED record Report an error
Toxoplasma reagents - other W0105050199 – 98/79 EUDAMED record Report an error
Viral antigen/antibody detection - other W0105040699 – 98/79 EUDAMED record Report an error
Adenovirus W0105040601 – 98/79 EUDAMED record Report an error
Coronavirus / influenza - RT & POC W0105090601 – 98/79 EUDAMED record Report an error
Dengue - RT & POC W0105099007 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004 – 98/79 EUDAMED record Report an error
Parasitology - other W0105050299 – 98/79 EUDAMED record Report an error
Rubella virus reagents - other W0105040199 – 98/79 EUDAMED record Report an error
Various general purpose IVD instruments - other W02079099 A IVDR EUDAMED record Report an error
Astrovirus W0105040629 – 98/79 EUDAMED record Report an error
Bacteriology immunoassay - other W0105011799 – 98/79 EUDAMED record Report an error
Bordetella pertussis / parapertussis W0105011707 – 98/79 EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection W0105011803 – 98/79 EUDAMED record Report an error
Campylobacter direct antigen detection W0105011401 – 98/79 EUDAMED record Report an error
Candida albicans W0105060302 – 98/79 EUDAMED record Report an error
Chikungunya virus W0105040625 – 98/79 EUDAMED record Report an error
Chlamydia ag - RT & POC W0105090101 C IVDR EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC W0105090502 – 98/79 EUDAMED record Report an error
Cryptococcus W0105060303 – 98/79 EUDAMED record Report an error
Cryptosporidium W0105050207 – 98/79 EUDAMED record Report an error
D-dimer W0103020503 – 98/79 EUDAMED record Report an error
D-dimer - RT & POC W0103020803 – 98/79 EUDAMED record Report an error
E. coli direct antigen detection W0105011501 – 98/79 EUDAMED record Report an error
Entamoeba histolytica W0105050201 – 98/79 EUDAMED record Report an error
Enterovirus W0105040602 – 98/79 EUDAMED record Report an error
Giardia lamblia W0105050208 – 98/79 EUDAMED record Report an error
Gonococcal antigen detection W0105010201 – 98/79 EUDAMED record Report an error
H. pylori antigen detection W0105010401 – 98/79 EUDAMED record Report an error
Hbsag - RT & POC W0105090201 – 98/79 EUDAMED record Report an error
HCV antibody -RT & POC W0105090202 – 98/79 EUDAMED record Report an error
HIV 1 / 2 - RT & POC W0105090302 – 98/79 EUDAMED record Report an error
HPV antigen / antibodies W0105041001 – 98/79 EUDAMED record Report an error
Hsv 1+2 igm W0105040304 – 98/79 EUDAMED record Report an error
Human metapneumovirus W0105040617 – 98/79 EUDAMED record Report an error
Infectious immunology - other W0105900299 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
Legionella - RT & POC W0105090108 – 98/79 EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC W0105099003 – 98/79 EUDAMED record Report an error
Mycoplasma antibody assays W0105010802 – 98/79 EUDAMED record Report an error
Norovirus W0105040616 – 98/79 EUDAMED record Report an error
Rotavirus W0105040606 – 98/79 EUDAMED record Report an error
Salmonella antibody assays W0105011002 – 98/79 EUDAMED record Report an error
Salmonella antigen detection W0105011001 – 98/79 EUDAMED record Report an error
Streptococcal direct antigen detection W0105011101 – 98/79 EUDAMED record Report an error
Tetanus (clostridium t.) W0105011709 – 98/79 EUDAMED record Report an error
Varicella zoster virus igm W0105040903 – 98/79 EUDAMED record Report an error
Zika virus W0105040630 – 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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