Manufacturer

Aconbio

ChinaLegal entities : Acon Biotech (Hangzhou) Co., Ltd.

First countries of placing on the market declared in EUDAMED : Germany, Ireland, Poland, Portugal, Romania

EU representative : MedNet EC-REP GmbH (Germany)

41 categories, 97 models including 97 on the market, 1 country

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
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	FIAflex Fluorescent Immunoassay Analyzer(iFIA-800)2 refs Mission98/79 Mission Cholesterol Meter CCM-1114 refs Mission Plus98/79 Mission Ultra Cholesterol Meter CCM-1014 refs 10 others On Call GK Dual Blood Ketone Meter OGM-161 On Call GU Dual Blood Glucose & Uric Acid Meter OGM-201 On Call GU Dual Blood Glucose and Uric Acid Meter OGM-20198/79 On Call Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer OGM-36198/79 On Call Sure GK Blood Glucose & Ketone Meter OGM-5112 refs On Call Sure Sync GK Blood Glucose & Ketone Meter OGM-512 QUIK-CHECK98/79 QUIK-CHECK Cholesterol Meter CCM-11198/79 QUIK-CHECK Plus98/79 QUIK-CHECK Ultra Cholesterol Meter CCM-10198/79	A IVDR, 98/79	EUDAMED record Report an error
Blood glucose meters	W0201060102	On Call OGM-1512 refs On Call OGM-1914 refs On Call OGM-5413 refs On Call Extra Blood Glucose Meter OGM-1913 refs98/79 On Call EZ II Blood Glucose Meter OGM-15198/79 5 others On Call OGM-2114 refs On Call OGM-2124 refs On Call Plus Blood Glucose Meter OGM-5412 refs98/79 On Call Sure Blood Glucose Meter OGM-2113 refs98/79 On Call Sure Sync Blood Glucose Meter OGM-2123 refs98/79	C IVDR, 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	FIAflex98/79 FIAflex Dengue NS1 Ag FIA Test98/79 Flowflex2 refs98/79 Flowflex Dengue NS1 Ag & IgG/IgM Combo Rapid Test Cassette (Serum/Plasma/Whole Blood)98/79 Flowflex Dengue NS1 Ag FIA Test98/79 1 other Quik-Check98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Promotor Nucleic Acid (DNA) Extraction Kit3 refs Promotor Nucleic Acid (RNA) Extraction Kit3 refs Promotor Nucleic Acid Extraction Kit Promotor Viral DNA/RNA Isolation Kit2 refs Promotor Viral Nucleic Acid Isolation Kit 1 other Promotor Whole Blood Genomic DNA Extraction Kit2 refs	A IVDR	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	FIAflex SARS-CoV-2 Antigen FIA98/79 Flowflex SARS-CoV-2 Antigen FIA98/79 Flowflex SARS-CoV-2 Antigen Rapid Test4 refs98/79 Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)2 refs98/79 Flowflex SARS-CoV-2 Antigen Rapid Test Slim2 refs98/79	– 98/79	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	Mission Expert U120 Smart Urine Analyzer2 refs Mission Expert U500 Urine Analyzer3 refs Mission U120 Smart Urine Analyzer2 refs Mission U500 Urine Analyzer3 refs	A IVDR	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	FIAflex98/79 Flowflex5 refs98/79 Influenza A/B Rapid Test (Self-Testing) L031-1193598/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	FIAflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79 Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test98/79 Flowflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Flowflex98/79 Flowflex SARS-CoV-2 & Flu A/B & RSV Antigen Combo Rapid Test2 refs98/79 Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop(Saliva))98/79	– 98/79	EUDAMED record Report an error
Blood collection, capillary tubes	W0501010203	Mission Capillary Transfer Tubes CCA-1013 refs Mission Capillary Transfer Tubes CCA-1032 refs	A IVDR	EUDAMED record Report an error
Chemistry instruments - other	W02010199	Mission Hb Hemoglobin Meter2 refs Mission Plus Hb Hemoglobin Meter2 refs	A IVDR	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	FIAflex98/79 Flowflex98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Flowflex3 refs98/79 Quik-Check3 refs98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	FIAflex98/79 Flowflex98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	FIAflex98/79 Flowflex98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	FIAflex IL-6 FIA Test98/79 Flowflex IL-6 FIA Test98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Flowflex98/79 Quik-Check2 refs98/79	– 98/79	EUDAMED record Report an error
Samples transport, containers - other	W05020199	Promotor Sample Collection Kit Promotor Viral Transport Media3 refs	A IVDR	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Flowflex98/79 Quik-Check2 refs98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Flowflex2 refs98/79	– 98/79	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Mission HA-3602 refs98/79	– 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Mission HA-56098/79	– 98/79	EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection	W0105011803	Flowflex98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	Flowflex SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test4 refs98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	ACON SARS-CoV-2 IgG/IgM Rapid Test2 refs98/79	– 98/79	EUDAMED record Report an error
Enterovirus	W0105040602	Flowflex EV71 IgM Rapid Test98/79	– 98/79	EUDAMED record Report an error
Haematology reagents - other	W01030199	Mission 3D Hematology Reagent (Cyto-Diluent)3 refs	A IVDR	EUDAMED record Report an error
Haemoglobin controls	W0103010504	Mission CCC-17198/79	– 98/79	EUDAMED record Report an error
Haemoglobin determinations (total hb)	W0103010201	Mission CCS-1712 refs98/79	– 98/79	EUDAMED record Report an error
HIV 1 / 2 - RT & POC	W0105090302	ACON HIV 1/2/O Tri-line Rapid Test Cassette (Serum/Plasma/Whole blood)3 refs	D IVDR	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	FIAflex FIA Analyzer iFIA-1002 refs	A IVDR	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Flowflex98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	Flowflex98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	Promotor 960 Real-Time PCR System RTQ-960	A IVDR	EUDAMED record Report an error
Rotavirus	W0105040606	Flowflex98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Flowflex98/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Flowflex2 refs98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Flowflex98/79	– 98/79	EUDAMED record Report an error
Turbidimeters	W0201020205	On Call MultiPro Analyzer OGM-2212 refs	A IVDR	EUDAMED record Report an error
Various hematology / histology / cytology instruments - other	W02029099	Mission CCM-17198/79	– 98/79	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Promotor NES-32 Nucleic Acid Extraction System	A IVDR	EUDAMED record Report an error

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