Manufacturer

Aichek

ChinaLegal entities : Hangzhou Aichek Medical Technology Co., Ltd.

Markets : Austria · Belgium · Netherlands · Spain · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class I, II · latest in 2024 · see on the FDA website

EU representative : Medunion S.L. (Spain)

ra.rep@aichek.com

34 categories, 52 models including 52 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Other multiple pathogens - RT & POC	W0105090699	COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test COVID-19/ Influenza A+B/RSV Antigen Combo Rapid Test98/79 COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test98/79 Rotavirus/Adenovirus Antigen Combo Rapid Test RAV-F22a98/79 Salmonella typhi & Salmonellaparatyphi Antigen Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	HSV IgG/IgM Rapid Test HSV-D02a98/79 Norovirus Antigen Rapid Test NOV-F02a98/79 Rotavirus Antigen Rapid Test ROTA-F02a98/79 Typhoid Antigen Rapid Test98/79 Zika IgG/lgM Antibody Rapid Test98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM Rapid Test DEAB-D02a98/79 Dengue IgG/IgM/NS1 Combo Rapid Test98/79 Dengue NS1 Rapid Test98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f. Antigen Rapid Test MAL-D02a98/79 Malaria P.f./P.an. Rapid Test MAL-D22a98/79 Malaria P.f./P.v. Rapid Test MAL-D22b98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	AI 1000 AI 600	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	AI 1600,AI 1610,AI 1620,AI 1630 AI 2600, AI 2610, AI 2620, AI 2660, AI 26802 refs	A IVDR	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Tuberculosis (TB) IgG/IgM Rapid Test98/79 Typhoid Antibody Rapid Test98/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	D-Dimer Rapid Test D-D-D02a98/79 D-Dimer Test Kit FIA98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. Pylori Antibody Rapid Test HP-D02a, HP-D01a98/79 H. Pylori Antigen Rapid Test HP-F02a98/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Chikungunya IgG/lgM Antibody Rapid Test98/79 Leishmania IgG/IgM Antibody Rapid Test L-D22a98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - high routine (throughput > 700 test/h)	W0201020104	Automatic Chemiluminescence lmmunoanalyzer AI 8200, AI 8210,AI 8260	A IVDR	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	COVID-19&Influenza A+B Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	COVID-19 IgG/IgM Rapid Test98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	COVID-19 Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer (CLIA)98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Hp Ab Helicobacter Pylori Antibody (CLIA)98/79	– 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	Anti-HAV Hepatitis A Virus Antibody (CLIA)98/79	– 98/79	EUDAMED record Report an error
Hav antibody igm	W0105020104	Anti-HAV IgM Hepatitis A Virus IgM Antibody (CLIA)98/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	Hepatitis A Virus Antibody Rapid Test HAV-D02a98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igg	W0105040306	HSV - 1 IgG Herpes Simplex Virus Type 1 IgG Antibody (CLIA)98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	HSV - 2 IgG Herpes Simplex Virus Type 2 IgG Antibody (CLIA)98/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	AI 510F	A IVDR	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A+B Antigen Rapid Test FLU-B22b98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 Interleukin-6 (CLIA)98/79	– 98/79	EUDAMED record Report an error
Plasmin - a2 - antiplasmin complex	W0103020305	PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Respiratory Syncytial Virus (RSV) Antigen Rapid Test RSV-B02b98/79	– 98/79	EUDAMED record Report an error
Special coagulation tests - other	W0103020399	TM Thrombomodulin (CLIA)98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Antigen Rapid Test STA-B02b98/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Strep B Antigen Rapid Test STB-K02a98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Antibody Rapid Test SYP-D02a, SYP-D01a98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Anti-TP Treponema Pallidum Antibody (CLIA)98/79	– 98/79	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	TAT Thrombin-Antithrombin III Complex (CLIA)98/79	– 98/79	EUDAMED record Report an error
Tissue plasminogen activator	W0103020507	tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)98/79	– 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Fluorescence Immunoassay Analyzer AFE-101	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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