Manufacturer

Bioer

ChinaLegal entities : Anhui Bioer Technology Co., Ltd., Hangzhou Bioer Technology Co., Ltd.

Markets : Germany · Greece · United States

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

EU representative : MedNet EC-REP GmbH (Germany)

Website ra_oversea@bioer.com.cn

21 categories, 76 models including 76 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
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Category	EMDN code	Registered models	Class	Contact
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	AutoGene 9600 Automatic PCR Analysis System FQD-A9600(EA4), FQD-A9600(EA5), FQD-A9600(EA6)3 refs Automated Nucleic Acid Purification and Real Time PCR System FQD-A1600(EA4), FQD-A1600(EA5), FQD-A1600(EA6)3 refs Automated Nucleic Acid Purification System NPAs-9600,NPAs-96202 refs Bioquant-96m Fluorescent Quantitative Detection System careSTART™ Q1 Amplifier TQA-E00182 14 others CentriDx Automated Nucleic Acid Analyzer CentriDx 200(EA4) , CentriDx 200(EA5) , CentriDx 200(EA6)3 refs GeneExplorer Thermal Cycler GE-96G, GE-96S, GE-48DG, GE-384G, GE-4I, GE-48D, GE-48DS,GE-DX3 refs GenePure 96 Nucleic Acid Purification System NPA-96, NPA-96T, NPA-96E3 refs GenePure Pro 16H Nucleic Acid Purification System NPA-16H GenePure Pro 9600 Nucleic Acid Purification System NPAm-9600 GenePure Pro Nucleic Acid Purification System NPA-32P, NPA-32E2 refs LineGene 9600 Plus Fluorescent Quantitative Detection System FQD-96A(EA2), FQD-96A(EA4), FQD-96A(EA5), FQD-96A(EA6)3 refs LineGene 9600 Pro Fluorescenct Quantitative Detection System FQD-96A(ED2), FQD-96A(ED4), FQD-96A(ED5), FQD-96A(ED6)3 refs LineGene K Plus Fluorescent Quantitative Detection System FQD-48A(EA2), FQD-48A(EA4)2 refs LineGene Mini Fluorescent Quantitative Detection System FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4)3 refs LineGene MiniS Fluorescent Quantitative Detection System FQD-16B(EA2) , FQD-16B(EA4)2 refs QuantFlex Fluorometer QuantFlex 800 QuantGene 9600 Fluorescent Quantitative Detection System FQD-96C(EA4), FQD-96C(EA5), FQD-96C(EA6)3 refs VitroCycler Fluorescent Quantitative Detection System VIT-VitroCycler	A IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Biospin Omni Genomic DNA Extraction Kit BSC39S1, BSC39M12 refs Biospin Virus DNA/RNA Extraction Kit BSC77S1, BSC77M1, BSC77L13 refs MagaBio FFPE Tissue Genomic DNA Purification Kit BSC31S1, BSC31M1, BSC31M1S, BSC31N1E, BSC31T1S, BSC31S1S, BSC31M1E, BSC31L1E, BSC31T1E, BSC31S1E, BSC31T1C, BSC31S1C, BSC31M1E-T, BSC31L1E-T, BSC31T1C-C, BSC31S1C-C, BSC31S1P-A3 refs MagaBio FFPE Tissue Genomic DNA/RNA Purification Kit BSC118T1S, BSC118S1S, BSC118M1S, BSC118N1E, BSC118T1E, BSC118S1E, BSC118M1E, BSC118L1E, BSC118T1C-C, BSC118S1C-C, BSC118M1E-T, BSC118L1E-T, BSC118S1B, BSC118M1B, BSC118S1P-A3 refs MagaBio FFPE Tissue RNA Purification Kit BSC36S1, BSC36M1, BSC36M1S, BSC36N1E, BSC36T1S, BSC36S1S, BSC36M1E, BSC36L1E, BSC36T1E, BSC36S1E, BSC36M1E-T, BSC36L1E-T, BSC36T1C-C,BSC36S1C-C, BSC36S1P-A3 refs 8 others MagaBio plus General Genomic DNA Purification Kit Ⅱ BSC74S1B, BSC74M1B, BSC74M1S, BSC74N1E, BSC74T1S, BSC74S1S, BSC74M1E, BSC74L1E, BSC74T1E, BSC74S1E, BSC74T1C, BSC74S1C, BSC74M1E-T, BSC74L1E-T, BSC74T1C-C, BSC74S1C-C, BSC74S1P-A3 refs MagaBio plus Virus DNA / RNA Purification Kit Ⅱ BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T3 refs MagaBio plus Virus DNA /RNA Purification Kit VI BSC110S1B, BSC110M1B, BSC110T1S, BSC110S1S, BSC110M1S, BSC110N1E, BSC110T1E, BSC110S1E, BSC110M1E, BSC110L1E, BSC110T1P, BSC110S1P, BSC110M1E-T, BSC110L1E-T, BSC110T1C, BSC110S1C, BSC110T1C-C, BSC110S1C-C, BSC110S1P-A3 refs MagaBio plus Virus RNA Purification Kit Ⅱ BSC87T1S, BSC87S1S, BSC87M1S, BSC87N1E, BSC87T1E, BSC87S1E, BSC87M1E, BSC87L1E, BSC87S1B, BSC87M1B, BSC87M1E-T, BSC87L1E-T, BSC87T1P, BSC87S1P3 refs MagaBio plus Whole Blood Genomic DNA Purification Kit BSC08S1B, BSC08M1B, BSC08T1P, BSC08S1P, BSC08T1S, BSC08S1S, BSC08M1S, BSC08T1E, BSC08S1E, BSC08M1E, BSC08L1E, BSC08T1C, BSC08S1C, BSC08M1E-T, BSC08L1E-T, BSC08T1C-C, BSC08S1C-C, BSC08N1E, BSC08S1P-A3 refs MagaBio plus Whole Blood Genomic DNA Purification Kit II BSC73S1B, BSC73M1B, BSC73T1P, BSC73S1P, BSC73T1S, BSC73S1S, BSC73M1S, BSC73L1E, BSC73T1E, BSC73S1E BSC73M1E, BSC73N1E, BSC73S1P-A, BSC73T1C, BSC73S1C, BSC73M1E-T, BSC73L1E-T, BSC73T1C-C, BSC73S1C-C3 refs MagaBio plus Whole Blood Total RNA Purification Kit II BSC133S1B, BSC133M1B, BSC133T1S, BSC133S1S, BSC133T1E, BSC133S1E, BSC133M1S, BSC133N1E, BSC133T1C, BSC133S1P-A, BSC133M1E, BSC133L1E, BSC133S1C, BSC133T1C-C, BSC133M1E-T, BSC133L1E-T, BSC133S1C-C3 refs Simply P Virus DNA/RNA Extraction Kit BSC67S1, BSC67M1, BSC67L13 refs	A IVDR	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Bocavirus, Human Metapneumovirus and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ12L198/79 Bocavirus, Human Metapneumovirus and Rhinovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ12M198/79 CentriDxTM Lower Respiratory Pathogen Panel Ⅰ BSJ62S198/79 CentriDxTM Respiratory Pathogen Panel V BSJ84S198/79 Respiratory Syncytial Virus/ Adenovirus/Parainfluenza Virus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ45L198/79 7 others Respiratory Syncytial Virus/ Adenovirus/Parainfluenza Virus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ45M198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Lyophilized Nucleic Acid Detection Kit (Fluorescence PCR) BSJ48M198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Lyophilized Nucleic Acid Detection Kit (Fluorescence PCR) BSJ48S198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Nucleic Acid Multiple Detection Kit (Fluorescence PCR) BSJ37L198/79 SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Nucleic Acid Multiple Detection Kit (Fluorescence PCR) BSJ37M198/79 Streptococcus Pneumoniae and Haemophilus Influenzae Nucleic Acid Detection Kit (Fluorescence PCR) BSJ31L198/79 Streptococcus Pneumoniae and Haemophilus Influenzae Nucleic Acid Detection Kit (Fluorescence PCR) BSJ31M198/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	CentriDxTM Gastrointestinal Pathogen Panel Ⅰ BSJ87S198/79 Norovirus/Group A Rotavirus/Enteric Adenovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ35L198/79 Norovirus/Group A Rotavirus/Enteric Adenovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ35M198/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Human Parainfluenza Virus Type 1, Type 2, Type 3 Nucleic Acid Detection Kit (Fluorescence PCR) BSJ11L198/79 Human Parainfluenza Virus Type 1, Type 2, Type 3 Nucleic Acid Detection Kit (Fluorescence PCR) BSJ11M198/79 Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR) BSJ04S1, BSJ04M1, BSJ04L13 refs	B IVDR, 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Adenovirus and Adenovirus type 3, 4 and 7 Nucleic Acid Detection Kit (Fluorescent PCR) BSJ06M198/79 Adenovirus and Adenovirus type 3, 4 and 7 Nucleic Acid Detection Kit (Fluorescent PCR) BSJ06S198/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	SARS-CoV-2 Lyophilized Nucleic Acid Detection Kit BSJ18S198/79 SARS-CoV-2 Lyophilized Nucleic Acid Detection Kit BSJ18S1S98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Dengue Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ43L198/79 Dengue Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ43M198/79	– 98/79	EUDAMED record Report an error
Hepatitis a virus - NA reagents	W0105020105	Hepatitis A Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ51M198/79 Hepatitis A Virus Nucleic Acid Detection Kit (Fluorescent PCR) BSJ51S198/79	– 98/79	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	Enterovirus Universal, Enterovirus 71, Coxsackievirus A6, Coxsackievirus A10 and Coxsackievirus A16 nucleic acid Detection Kit (Fluorescent PCR) BSJ26L198/79 Enterovirus Universal, Enterovirus 71, Coxsackievirus A6, Coxsackievirus A10 and Coxsackievirus A16 nucleic acid Detection Kit (Fluorescent PCR) BSJ26M198/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	HPV Nucleic Acid Detection and 16/18 Genotyping Kit (Fluorescent PCR) BSJ50L198/79 HPV Nucleic Acid Detection and 16/18 Genotyping Kit (Fluorescent PCR) BSJ50M198/79	– 98/79	EUDAMED record Report an error
Samples collection devices - other	W05019099	Sample Preservative Fluid BSC82S1, BSC82M1, BSC82L1, BSC82N1, BSC82X1-A, BSC82X1-B, BSC82N1-1, BSC82X1-A1, BSC82X1-B1, BSC82X1-C1, BSC82X1-E1, BSC82N1-2, BSC82X1-A2, BSC82X1-B2, BSC82X1-C2, BSC82X1-E23 refs Universal Transport Medium BSC93X1-B3	A IVDR	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	CentriDxTM Sexually Transmitted Disease Panel I BSJ69S198/79 Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR) BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A3 refs	C IVDR, 98/79	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	Group A Streptococcus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ38L198/79 Group A Streptococcus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ38M198/79	– 98/79	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	Monkeypox Virus Nucleic Acid Multiple Detection Kit (Fluorescent PCR) BSJ34M198/79 Monkeypox Virus Nucleic Acid Multiple Detection Kit (Fluorescent PCR) BSJ34S198/79	– 98/79	EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	HPV Genotyping Real-Time PCR Kit (Fluorescent PCR) BSJ01M1， BSJ01L12 refs	C IVDR	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	CentriDxTM Meningitis/Encephalitis Pathogen Panel Ⅰ BSJ97S198/79	– 98/79	EUDAMED record Report an error
Mycoplasma pneumoniae detection by NA reagents	W010501080301	Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR) BSJ09S1, BSJ09M1, BSJ09L13 refs	B IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR) BSJ05S1, BSJ05M1, BSJ05L13 refs	B IVDR	EUDAMED record Report an error
Samples transport, containers - other	W05020199	96 well cell culture plate BHW05S1-S	A IVDR	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	CentriDxTM Tropical Fever Pathogen Panel Ⅰ BSJ96S198/79	– 98/79	EUDAMED record Report an error

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