Manufacturer

Yanengbio

ChinaLegal entities : Yaneng BIOscience (Shenzhen) Co., Ltd.

First countries of placing on the market declared in EUDAMED : Italy

EU representative : Obelis s.a. (Belgium)

16 categories, 34 models including 34 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
Supplemental NA reagents	W0105900103	Nucleic Acid Extraction Reagent Human Whole Blood DNA (Spin-Column) Nucleic Acid Extraction Reagent MEB-16C, MEB-96C, MEB-100F, MEB-16D, MEB-96D Nucleic Acid Extraction Reagent MNS-16C; MNS-48F Nucleic Acid Extraction Reagent QIA Sample Pretreatment Kit for DNA Methylation Test BS 1 other Sample Pretreatment Kit for DNA Methylation Test MBS-16C; MBS-48F	A IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Nucleic Acid Extraction Reagent MCP-16C, MCP-96C, MCP-100F, MCP-96E Nucleic Acid Extraction Reagent MEG-16C, MEG-96C, MEG-100F Nucleic Acid Extraction Reagent MES-16C, MES-96C, MES-100F Nucleic Acid Extraction Reagent MNP-16C, MNP-96C, MNP-100F, MNP-96E Nucleic Acid Extraction Reagent Pathogen DNA (Spin-Column)	A IVDR	EUDAMED record Report an error
Samples transport, containers - other	W05020199	Cell Preservation Solution CPN Cell Preservation Solution Mucus removal type I Cell Preservation Solution Preservative Sample Preservation Solution Inactivated	A IVDR	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Automatic Nucleic Acid Extraction System YN-AP9610 Automatic Nucleic Acid Sample Processing System YN-PW9600 Automatic Reagent Pipetting System YN-MP9600	A IVDR	EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	Human Papillomavirus Genotyping Kit for 18 Types (PCR-Reverse Dot Blot)98/79 Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)2 refs98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Automatic Integrated Nucleic Acid Analyzer YN-AHR3210 Fully Automated Nucleic Acid Amplification Hybridization Analyzer YN-HR9600pro	A IVDR	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	Human Papillomavirus Genotyping Kit for 15 Types (PCR-Reverse Dot Blot)98/79 Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing)98/79	– 98/79	EUDAMED record Report an error
Urine collection, tubes	W05010202	Urine Collection Tube UPF Urine Collection Tube UPS	A IVDR	EUDAMED record Report an error
Capillary blood collection devices - other	W0501010299	Newborn Blood Spot Collection Card NBA, NBB, NBC	A IVDR	EUDAMED record Report an error
Cytochemical staining reagents	W01030702	DD Nucleic Acid Dye	A IVDR	EUDAMED record Report an error
Faeces collection devices	W05019001	Stool Collection Tube FPS	A IVDR	EUDAMED record Report an error
Immunohistology kits	W01030711	p16/ Ki-67 dual stain cytology kit DS	A IVDR	EUDAMED record Report an error
Nucleic acid hybridization units	W02050101	Automatic Hybridization System YN-H48	A IVDR	EUDAMED record Report an error
Other HPV - NA reagents	W0105041005	Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Respiratory Pathogens Combo Testing Kit98/79	– 98/79	EUDAMED record Report an error
Strep. b detection by NA reagents	W0105011104	Group B Streptococcus Nucleic Acid Detection Kit (Real-Time PCR)98/79	– 98/79	EUDAMED record Report an error

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