Manufacturer

Ningbo HEALTH Gene Technologies

ChinaLegal entities : Ningbo HEALTH Gene Technologies Co., LTD.

Markets : Poland · Spain

Approvals : EU – class A

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

8 categories, 26 models including 26 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
Virology - NA reagents - other	W0105040599	13Respiratory Pathogen Multiplex Detection Kit (PCR Capillary Electrophoresis Fragment Analysis)98/79 Influenza A/B Virus Nucleic Acid Rapid Test Kit (colloidal gold)98/79 Influenza A/B Virus, Respiratory Syncytial Virus, Adenovirus and Mycoplasma Pneumonia Nucleic Acid Detection Kit98/79 Meningitis/Encephalitis Pathogen Multiplex Detection Kit(PCR-Capillary Electrophoresis Fragment Analysis)98/79 Monkeypox virus Detection Diagnostic Kit (qPCR Method)98/79 3 others Monkeypox virus Nucleic Acid Rapid Detection Kit(colloidal gold)98/79 Monkeypox virus Nucleic Acid Rapid Detection Kit(Fluorescence)98/79 SRAS-CoV-2 virus, Influenza A/B virus, Respiratory syncytial virus and Adenovirus nucleic acid Detection kit (RT-qPCR)98/79	– 98/79	EUDAMED record Report an error
IVD general use consumable devices - other	W0599	Fluorescent Internal Standard Dyes2 refs Nucleic Acid Extraction or Purification Kit2 refs Nucleic Acid Extraction or Purification Kit XB03076 Nucleic Acid Extraction or Purification Kit XB16028 Polymer Gel A01010012	A IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	A-32 A-32min A-96 L-20	A IVDR	EUDAMED record Report an error
IVD instruments - other	W0299	PD-50 TQL-6300	A IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	CE2400 T400	A IVDR	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	HPV Genotyping Kit (PCR capillary analysis) (F650)98/79 HPV Genotyping Kit (PCR-Capillary Electrophoresis Fragment Analysis) (F488)98/79	– 98/79	EUDAMED record Report an error
Samples collection devices - other	W05019099	Disposable virus sampling tube Sample Preservation Solution XB06050	A IVDR	EUDAMED record Report an error
DNA genomic preparation devices	W02050106	ES400	A IVDR	EUDAMED record Report an error

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