Manufacturer

Jiangsu Mole Bioscience

ChinaLegal entities : Jiangsu Mole Bioscience Co., LTD.

Markets : Bulgaria · Croatia · Czechia · Finland · Germany · Greece · Lithuania · Luxembourg · Netherlands · Romania · Slovakia · Spain

Approvals : EU – class A

EU representative : Lotus NL B.V. (Netherlands)

28 categories, 54 models including 54 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
IVD instruments - other	W0299	Automated Nucleic Acid Extraction System (Mole 32M) Automated Nucleic Acid Extraction System (Mole 96M) Automated Nucleic Acid Extraction System (Mole Fast96) Automatic nucleic acid extractor (MLN32) Automatic Nucleic Acid Extractor (MLN96) 2 others Automatic Nucleic Acid Extractor (Pure32) Pure16	A IVDR	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)11 refs98/79 2019-Novel Coronavirus, Influenza A and B Virus Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)2 refs98/79 2019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial Virus Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay)98/79 SARS-CoV-2 Realtime PCR Test Kit (Lyophilized)4 refs98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Dengue Virus Genotyping Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Dengue virus nucleic acid test kit (Fluorescent Probe-based Real-time PCR Assay)3 refs98/79 Kit de Prueba de Ácido Nucleico del Virus del Dengue (Ensayo de PCR en tiempo real basado en sonda fluorescente)98/79	– 98/79	EUDAMED record Report an error
H. pylori detection by NA reagents	W0105010403	Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)2 refs98/79 H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit3 refs98/79 Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A H1N1(2009) Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Influenza A&B Rapid Test Cassette R084T020B0C098/79 Influenza A&B Rapid Test Cassette R501T020B0C098/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Nucleic Acid Extraction Kit (Boiling Method)3 refs Nucleic Acid Extraction Kit (Spin Column)3 refs Nucleic Acid Extraction Kit P01911P20643 refs	A IVDR	EUDAMED record Report an error
Bocavirus	W0105040618	Flu A/B + COVID-19 Antigen Combo Test Cassette Kit2 refs98/79 SARS-CoV-2 Antigen Test Cassette2 refs98/79	– 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	Clostridium difficile nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)3 refs98/79 Clostridium Difficile TcdA Gene And TcdB Gene Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Candida auris - NA reagents	W0105060404	Candida auris and Antibiotic-Resistant Strain Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 Candida Auris Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Devices for samples transport - other	W050299	Nucleic Acid Release Reagent P049T055012 refs Sample Preservation Solution PG03010N01T20503 refs	A IVDR	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	EV71, CA16 and Other Enteroviral Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)5 refs98/79	– 98/79	EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe- Based Real- Time PCR Assay)15 refs98/79 Human Papillomavirus Nucleic Acid Amplification Test Kit (FluorescentProbe-based Real-time PCR Assay）98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Gastrointestional Infections Multiplex Real Time PCR Detection Kit98/79 Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based Real-time PCR Assay)98/79 Multi Respiratory Pathogen Real Time PCR Detection Kit5 refs98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	FLU A&B &COVID-19 & RSV & Adeno Antigen Combo Test Cassette98/79 SARS-CoV-2 & FLU A&B & RSV Antigen Combo Test Cassette98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae detection by NA reagents	W0105010118	Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit2 refs98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	Helicobacter Pylori (Hp) Antigen Test Kit98/79	– 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	Herpes Simplex Virus Type I and Type II Typing Nucleic Acid Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent	W0105040532	Monkeypox Virus Nucleic Acid Detection Kit (Fluorescent Probe-based Real-time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Multiple infectious - multiplex assays - other	W0105070599	FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette98/79	– 98/79	EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents	W0105070502	Bloodstream Infections Multiplex Real Time PCR Detection Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	Human Leukocyte Antigen B27 Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Rubella - NA reagents	W0105040104	Rubella And Measles Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Saliva collection devices	W05019002	Saliva Collection Kit PS01005F04C20103 refs	A IVDR	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	Urological and Reproductive Tract Microbial Nucleic Acid Test Kit(Fluorescent Probe-Based Real-Time PCR Assay)98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Antigen Test Kit R226T020B0C098/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	Zika virus, Dengue virus and Chikungunya virus Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)98/79	– 98/79	EUDAMED record Report an error

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