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Emdyca

Manufacturer

Hangzhou Alltest Biotech

ChinaLegal entities : Hangzhou Alltest Biotech.Co.,Ltd.

Markets : Austria · Belgium · Croatia · Czechia · France · Germany · Greece · Iceland · Ireland · Italy · Latvia · Lithuania · Netherlands · Norway · Poland · Portugal · Slovakia · Slovenia · Spain · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 14 · class I, II · latest in 2026 · see on the FDA website

EU representative : MedNet EC-REP GmbH (Germany)

info@alltests.com.cn

122 categories, 894 models including 894 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Other multiple pathogens - RT & POC W0105090699
130 others
 – 98/79 EUDAMED record Report an error
Bacteriology - RT & POC - other W0105090199
74 others
 C IVDR, 98/79 EUDAMED record Report an error
Virology - RT & POC - other W0105099099
71 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Controls infectious immunology - RT & POC W0105094001
56 others
 – 98/79 EUDAMED record Report an error
Multiple infectious - multiplex assays - other W0105070599
22 others
 – 98/79 EUDAMED record Report an error
H. pylori - RT & POC W0105090102
20 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Multiple viruses - multiplex assays - other W0105070399
15 others
 – 98/79 EUDAMED record Report an error
Strep. a - RT & POC W0105090103
14 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401
13 others
 C IVDR, 98/79 EUDAMED record Report an error
Parasites - RT & POC - other W0105090499
12 others
 – 98/79 EUDAMED record Report an error
Dengue - RT & POC W0105099007
10 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC W0105090106
9 others
 – 98/79 EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC W0105090501
8 others
 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004
8 others
 C IVDR, 98/79 EUDAMED record Report an error
Syphilis - RT & POC W0105090105
8 others
 C IVDR, 98/79 EUDAMED record Report an error
Immunochemistry readers W0201020201
7 others
 A IVDR, 98/79 EUDAMED record Report an error
Viral antigen/antibody detection - other W0105040699
6 others
 B IVDR, 98/79 EUDAMED record Report an error
Coronavirus ag W0105041101
5 others
 – 98/79 EUDAMED record Report an error
Strep. pneumoniae - RT & POC W0105090109
5 others
 C IVDR, 98/79 EUDAMED record Report an error
Virology - NA reagents - other W0105040599
4 others
 – 98/79 EUDAMED record Report an error
Zika virus W0105040630
4 others
 – 98/79 EUDAMED record Report an error
Salmonella antigen detection W0105011001
3 others
 – 98/79 EUDAMED record Report an error
Salmonella antibody assays W0105011002
2 others
 – 98/79 EUDAMED record Report an error
Adenovirus W0105040601
1 other
 – 98/79 EUDAMED record Report an error
Combined abo typing + rhesus d W0103030901
1 other
 – 98/79 EUDAMED record Report an error
Coronavirus igg W0105041103
1 other
 – 98/79 EUDAMED record Report an error
D-dimer W0103020503
1 other
 – 98/79 EUDAMED record Report an error
H. pylori antibody assays W0105010402
1 other
 – 98/79 EUDAMED record Report an error
H. pylori antigen detection W0105010401
1 other
 – 98/79 EUDAMED record Report an error
HIV 1 / 2 - RT & POC W0105090302
1 other
 – 98/79 EUDAMED record Report an error
Monkeypox virus / mpox RT & POC W0105099008
1 other
 – 98/79 EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC W0105099003
1 other
 C IVDR, 98/79 EUDAMED record Report an error
Parasitology - other W0105050299
1 other
 – 98/79 EUDAMED record Report an error
Chikungunya virus W0105040625 – 98/79 EUDAMED record Report an error
Coronavirus / influenza - RT & POC W0105090601 – 98/79 EUDAMED record Report an error
Influenza & para influenza W0105040604 – 98/79 EUDAMED record Report an error
Legionella - RT & POC W0105090108 C IVDR, 98/79 EUDAMED record Report an error
Plasmodium (malaria) W0105050209 – 98/79 EUDAMED record Report an error
Rsv - RT & POC W0105099002 – 98/79 EUDAMED record Report an error
Urinalysis (ur) - laboratory analysers- instruments W02010701 A IVDR, 98/79 EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099 A IVDR, 98/79 EUDAMED record Report an error
C.difficile GDH detection W0105011801 – 98/79 EUDAMED record Report an error
Candida albicans W0105060302 – 98/79 EUDAMED record Report an error
Chagas W0105050202 – 98/79 EUDAMED record Report an error
Coronavirus antibodies - total W0105041102 – 98/79 EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC W0105090502 – 98/79 EUDAMED record Report an error
Dengue virus W0105040611 – 98/79 EUDAMED record Report an error
Hepatitis viruses - RT & POC - other W0105090299 – 98/79 EUDAMED record Report an error
Shigella W0105011714 – 98/79 EUDAMED record Report an error
Strep. b - RT & POC W0105090104 – 98/79 EUDAMED record Report an error
Tetanus (clostridium t.) W0105011709 – 98/79 EUDAMED record Report an error
Trichomonas W0105050210 – 98/79 EUDAMED record Report an error
Virology reagents - other W01050499 – 98/79 EUDAMED record Report an error
Bacteriology controls - inf.imm. W0105080801 – 98/79 EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection W0105011803 – 98/79 EUDAMED record Report an error
Chlamydia ag - RT & POC W0105090101 C IVDR, 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 - RT & POC W0103020803 – 98/79 EUDAMED record Report an error
Ebv antibodies - other W010504040199 – 98/79 EUDAMED record Report an error
Hbsag - RT & POC W0105090201 – 98/79 EUDAMED record Report an error
HCV antibody (total) W0105020303 – 98/79 EUDAMED record Report an error
HPV antigen / antibodies W0105041001 – 98/79 EUDAMED record Report an error
Hsv 1+2 antibodies - total W0105040302 – 98/79 EUDAMED record Report an error
Hsv 1+2 igm W0105040304 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
Leishmania W0105050205 – 98/79 EUDAMED record Report an error
Leptospira W0105011704 – 98/79 EUDAMED record Report an error
Mycobacterial antibody assays W0105010702 – 98/79 EUDAMED record Report an error
Mycoplasma antibody assays W0105010802 – 98/79 EUDAMED record Report an error
Mycoplasma antigen detection W0105010801 – 98/79 EUDAMED record Report an error
Syphilis antibody assays total W0105010302 – 98/79 EUDAMED record Report an error
Astrovirus W0105040629 – 98/79 EUDAMED record Report an error
Chlamydia trachomatis antigen detection W0105010107 – 98/79 EUDAMED record Report an error
Cmv igm W0105040204 – 98/79 EUDAMED record Report an error
Ebv ebna igg W010504040106 – 98/79 EUDAMED record Report an error
Ebv vca igg W010504040105 – 98/79 EUDAMED record Report an error
Entamoeba histolytica W0105050201 – 98/79 EUDAMED record Report an error
Giardia lamblia W0105050208 – 98/79 EUDAMED record Report an error
Hav antibody igm W0105020104 – 98/79 EUDAMED record Report an error
HCV antibody -RT & POC W0105090202 – 98/79 EUDAMED record Report an error
Hev antibody (total) W0105020503 – 98/79 EUDAMED record Report an error
Hev reagents - other W0105020599 – 98/79 EUDAMED record Report an error
Hsv 2 antibodies - total W0105040308 – 98/79 EUDAMED record Report an error
Hsv reagents - other W0105040399 – 98/79 EUDAMED record Report an error
Norovirus W0105040616 – 98/79 EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents W0105070503 – 98/79 EUDAMED record Report an error
Rotavirus W0105040606 – 98/79 EUDAMED record Report an error
Rubella virus igm W0105040103 – 98/79 EUDAMED record Report an error
Toxoplasma reagents - other W0105050199 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
Brucella W0105011701 – 98/79 EUDAMED record Report an error
E. coli direct antigen detection W0105011501 – 98/79 EUDAMED record Report an error
Enterovirus W0105040602 – 98/79 EUDAMED record Report an error
Gonococcal antigen detection W0105010201 – 98/79 EUDAMED record Report an error
Haemoglobin (hb) W0103010601 – 98/79 EUDAMED record Report an error
Haemoglobin determinations (total hb) W0103010201 – 98/79 EUDAMED record Report an error
Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1) W0103010202 – 98/79 EUDAMED record Report an error
Hantavirus / bunyavirus W0105040614 – 98/79 EUDAMED record Report an error
Hav antibody (total) W0105020102 – 98/79 EUDAMED record Report an error
Hev antibody igm W0105020505 – 98/79 EUDAMED record Report an error
Hsv 1 antibodies - total W0105040305 – 98/79 EUDAMED record Report an error
Hsv 1+2 igg W0105040303 – 98/79 EUDAMED record Report an error
Hsv antigen W0105040301 – 98/79 EUDAMED record Report an error
Human metapneumovirus W0105040617 – 98/79 EUDAMED record Report an error
Human metapneumovirus - NA reagents W0105040517 – 98/79 EUDAMED record Report an error
Legionella antigen detection W0105010501 – 98/79 EUDAMED record Report an error
Lyme antibody total W0105010602 – 98/79 EUDAMED record Report an error
Lyme borreliosis reagents - other W0105010699 – 98/79 EUDAMED record Report an error
Measles virus antibodies - total W0105040701 – 98/79 EUDAMED record Report an error
Measles virus igg W0105040702 – 98/79 EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent W0105040532 – 98/79 EUDAMED record Report an error
Norovirus - NA reagents W0105040516 – 98/79 EUDAMED record Report an error
Other antigen typing reagents W0103030501 – 98/79 EUDAMED record Report an error
Parasitology controls - inf.imm. W0105080805 – 98/79 EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - other W02020699 A IVDR EUDAMED record Report an error
Respiratory syncytial virus (rsv) W0105040605 – 98/79 EUDAMED record Report an error
Rhinovirus W0105040620 – 98/79 EUDAMED record Report an error
Strep. b detection by NA reagents W0105011104 – 98/79 EUDAMED record Report an error
Toxoplasma antibody (total) W0105050101 – 98/79 EUDAMED record Report an error
Toxoplasma antibody igm W0105050103 – 98/79 EUDAMED record Report an error
Varicella zoster virus igm W0105040903 – 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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